The National Academy for State Health Policy’s interactive Hospital Cost Tool provides a variety of hospital financial trends obtained from annual cost reports submitted directly from hospitals to the Centers for Medicare and Medicaid Services One key metric is the commercial breakeven, which represents the rate that could be charged to a hospital’s commercial payers in a given year that would allow the hospital to break even across all payer types, expressed as a percentage of that specific hospital’s Medicare payment rate. The Hospital Cost Tool also provides the RAND 4.0 Commercial Price from RAND’s Nationwide Evaluation of Health Care Prices Paid by Private Health Plans, which represents the percentage of a hospital’s Medicare payment rate that a hospital was reimbursed by commercial payers in aggregate from 2018 - 2020. Publicly available quality scores, such as the CMS Overall Hospital Quality Star Rating, and the Leapfrog Group Hospital Safety Grade provide an overall, consumer-friendly view of hospital quality.

As an example, Sammons Financial Group requested an overview of the hospitals in the main markets in which their employees live: Des Moines, IA; Ames, IA; and Sioux Falls, SD. BHC used the NASHP Hospital Cost Tool, CMS, and Leapfrog to create a snapshot of hospital quality and price in these markets.

“Thank you to the St Louis BHC Team for gathering the comprehensive data surrounding Iowa and South Dakota hospital pricing. The information is crucial for us as it helps in comparing the costs associated with different medical facilities. It was eye opening to say the least and I appreciated the insights from the BHC team to help in understanding the data.”

• Kathy Jacobs, HR Consultant, Sammons Financial Group.

BHC seeks to empower employers with actionable data specific to their community that can be used to drive improvements in health care quality and value. BHC members who are interested in an overview of hospitals where their employees get care can contact aball@stlbhc.org. 

Note*-  All three different types of vaccines can be given in one single setting if appropriate. Individuals should reach out to their local pharmacist or primary physician for additional information/questions.

Note*-  All three different types of vaccines can be given in one single setting if appropriate. Individuals should reach out to their local pharmacist or primary physician for additional information/questions.

• Identify unknown health issues such as CKD and heart disease 
• Avoid complications that could cause absence from work 
• Impact employee retention 
• Provide innovative low-cost benefits
• Drive both cost savings and proactive care
• Engage employees in their health
  
  

How to Participate

An emerging drug class, glucagon-like peptide-1 (GLP-1) receptor agonists, has demonstrated early success in the treatment of diabetes, and as a result, The American Diabetes Association has updated the clinical guidelines for the treatment of diabetes, bumping these therapeutics to “first in line” treatment. Plan sponsors are experiencing an increase in prescription costs associated with these treatments and this article seeks to improve employer understanding of the updated clinical guidelines and what plan sponsors can expect to see from providers within their communities due to the updated guidelines.

Previously, patients with type 2 diabetes were prescribed metformin as the initial treatment of diabetes and then given additional therapy to help manage their A1c. It is known that many patients with diabetes will suffer from complications and comorbidities such as cardiovascular disease, chronic kidney disease, high blood pressure, high cholesterol, and obesity. The updated approach focuses on providing patients with a single medication that will help treat multiple comorbidities along with diabetes. 

GLP-1 Receptor Agonists
Glucagon-like peptide-1 (GLP-1) receptor agonists have garnered a lot of attention in recent news due to various factors, such as endorsements by celebrities, increasing demand from consumers, as well as concerns over off-label usage. As a result, many employers have experienced an increase in utilization. In addition to improvements in diabetes treatment, studies have shown a cardiovascular benefit for patients with type 2 diabetes. Currently, medications Trulicity®, Ozempic®, and Victoza® are FDA approved to reduce the risk of cardiovascular events including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Medications in this class are known to help decrease food intake, delay gastric emptying, and enhance insulin secretion which may contribute to significant weight loss for patients who are obese in addition to lowering blood sugars. 
A newer GLP-1 agonist made by Eli Lilly called Mounjaro®, has made its mark this past year. It is currently only FDA approved for treatment of type 2 diabetes. Based on the initial clinical trial, patients had an average 22.5% weight reduction with using high doses. Trials are already on the way for approval for treatment of obesity, competing with Wegovy® and Saxenda®.

SGLT2 Inhibitors
Sodium glucose co-transporter 2 (SGLT2) inhibitors also have cardiovascular benefits specific for heart failure patients and may provide benefits for patients who suffer from chronic kidney disease (CKD). Currently Farxiga® and Invokana® are indicated for chronic kidney disease. Jardiance has an off label approval for CKD and all 3 medications are indicated for type 2 diabetes. Brenzavvy™ (bexagliflozin) was recently approved by the FDA on Jan. 20, 2023, becoming the fifth medication approved in this drug class.  These medications work by blocking reabsorption of filtered glucose, thereby reducing blood glucose.  

Action Steps for Employers:

1. Assess the current and potential diabetes medication utilization in your population. Collaborate with your partners to identify the present utilization and expenses linked to GLP-1s and SGLT2s, including their off-label use. Furthermore, request your partners to approximate the count of eligible employees and their family members who might require GLP-1s and SGLT2s, along with the health care expenses presently associated with that group, in order to evaluate both the potential additional expenses of providing coverage for these drugs and the potential long-term savings.
   
   
2. Communicate with your PBM to understand the utilization management tools available to ensure appropriate use. To ensure appropriate use of diabetes medications, prior and reauthorization processes for GLP-1s and SGLT2s should confirm that the drugs are being prescribed only for those who require them.

The U.S. Food and Drug Administration approved 37 novel drugs and 12 biologics in 2022. From Eli Lilly’s much-anticipated injectable, Mounjaro, for type 2 diabetes; to new treatments for psoriasis and HIV; and the gene therapy, Hemgenix, with a record-breaking $3.5 million price tag, the past year was filled with innovation across the pharmaceutical industry. So, what can employers and patients expect for 2023? BHC Pharmacy Program Coordinator, Kayley Delashmit, and Academic Detailing Pharmacist, Dr. Opal Chaudhary, explore the top products expected to make headlines.

Alzheimer’s Disease 

Recent controversary regarding FDA approval of Alzheimer’s medications has not slowed the pipeline of new therapies for this disease. In 2023, manufacturers are ready to show what they have been working on, moving forward to phase III trials. Eisai/Biogen awaits approval of their new medication, lecanemab. Eli Lilly is also anticipating approval for their medication, donanemab. These two medications will be the first disease-modifying agents to treat early stages of Alzheimer’s disease. Gantenerumab from Genentech, announced that it did not meet its primary endpoint in phase III trials. 

Sickle Cell Anemia & Transfusion-Dependent Beta Thalassemia 

Vertex and CRISPR Therapeutics are working on a gene editing therapy for patients who suffer from severe sickle cell anemia and transfusion-dependent beta thalassemia. For sickle cell anemia patients, this could help reduce or eliminate vaso-occlusive crisis, a painful complication of the disease. For transfusion-dependent beta thalassemia, the medication may help reduce the need for lifelong, regular blood transfusions. 

Hemophilia 

Following Hemgenix’s approval for Hemophilia B in 2022, Roctavian by Biomarin Pharmaceuticals, is expected to be approved for Hemophilia A in the spring. Gene therapy may be a potential cure for this disease, which causes patients to have frequent, spontaneous musculoskeletal and soft tissue bleeding. However, additional studies are needed to understand long-term effectiveness. 

HIV 

Gilead is seeking approval for a new HIV medication for patients that have suffered from medication resistance. Lenacapavir is a first-in-class capsid inhibitor that does not have a known cross-resistance to other existing drug classes. Patients with highly resistant HIV have a significant need for therapy that continues to be unmet. One unique detail about the medication is that it is a long-acting injectable that will be administered by a health care professional every six months. 

Depression 

Sage Therapeutics and Biogen’s new medication, zuranolone, will be seeking approval for two indications: major depressive disorder and post-partum depression. It will be introduced as a new drug class based on its unique, rapid mechanism action, compared to known antidepressants. If approved, this will be the first oral medication to be indicated to treat post-partum depression. It is a once a day, 14-day treatment. The manufacturers are also looking into other indications for approval. 

Stem Cell Transplant 

Omidubicel is a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. It has received “Breakthrough Therapy Designation” from the FDA and “Orphan Drug Designation.” In late January, its manufacturer, Gamida Cell, will be assigned a target date for the Prescription Drug User Fee Act. If approved by the FDA, this will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers who are unable to find a stem cell transplant match. 

Biosimilars 

Multiple biosimilars for Abbvie’s blockbuster drug, Humira, are set to hit the market in 2023. Up to 10 manufacturers are seeking launches for Humira biosimilars, with Amgen leading the way with its product Amjevita, launched on January 31.

Remember the Ice Bucket Challenge from 2014? The viral video trend helped raise an estimated $135 million worldwide for research on amyotrophic lateral sclerosis (ALS). This progressive neurodegenerative disease attacks motor neurons in the brain and spinal cord. Patients that suffer from this disease show symptoms of muscle wasting and loss of movement, which leads to permanent paralysis. Sadly, most people only live three to five years after diagnosis. There are an estimated 30,000 people in the US that are living with this disease.  

The Treatment
In September, Amylyx Pharmaceuticals announced that the FDA had approved their new medication Relyvrio (sodium phenylbutyrate/taurursodiol) in a phase 2 trial. Initially, the FDA panel voted against the approval stating there was “residual uncertainty about the evidence of effectiveness.” However, months later, the FDA panel reversed their decision when new results were provided. The phase 2 trial consisted of 137 ALS patients who would either receive Relyvrio or a placebo. Results indicated that patients treated with Relyvrio experienced a slower rate of decline on a clinical assessment of daily functioning compared to those receiving a placebo.

The Controversy
The FDA’s decision has already drawn criticism, with some saying that because the medication was under priority review and designated as an orphan drug (for rare diseases), the FDA may have felt compelled to approve the medication after receiving a letter from physicians who specialize in ALS. With a $158,000 price tag, there is also concern that the treatment’s cost is not justified by its limited outcomes data. The Institute for Clinical and Economic Review (ICER) has already conducted an evaluation of Relyvrio, stating that the “therapy would only achieve traditional thresholds of cost-effectiveness if priced between $9,100 to $30,700 per year.” With the phase 3 trial underway, many will be eager to see results regarding effectiveness, which are expected to be released in 2024. In the meantime, employers are faced with another difficult coverage decision, and the public is left to wonder if we need a watchdog to oversee the watchdog.

Gene Therapies
Gene therapies have been a hot topic in the pharmacy space for some time. After years of anticipation, gene therapies are beginning to enter the market, and are anticipated to have a big impact in 2023. In their initial review of Etranacogene Dezaparvovec, used for the treatment of Hemophilia B in adults, ICER found “encouraging results.” Patients who were administered the therapy saw an 80% reduction in treated joint bleeds and did not need to return to a prophylaxis regimen (IX factor therapy) for 18 months. It is not yet clear if this outcome will be maintained over multiple decades. While ICER’s final report has not been published, evidence suggests that Etranacogene Dezaparvovec is a promising treatment option for hemophilia patients and may result in overall lifetime savings for patients compared to traditional treatment. As this therapy is reviewed for approval by the FDA, employers should discuss coverage options with their medical plans, Pharmacy Benefit Managers, stop loss carriers, and consultants to determine potential financial risks based on their unique patient populations.

Weight Management Drugs
On Friday, September 16, ICER hosted a public meeting discussing the clinical and cost effectiveness of weight management drugs, including Novo Nordisk’s new subcutaneous semaglutide, Wegovy. While Wegovy has been demonstrated to help patients achieve greater weight loss when compared to other weight management drugs (e.g., liraglutide, naltrexone/bupropion), it comes at a significant cost. The list price of Wegovy in the US is nearly $14,000 per year after rebate, about 10 times higher than that in the UK). Based on its analysis, ICER recommends a health-benefit price benchmark of $7,500 to $9,800 annually, showing room for improvement in making these medications accessible and affordable for the 40% of US adults with obesity.

To learn more about ICER’s research and upcoming public meetings, please visit www.icer.org. 

The lawsuit between Johnson & Johnson (J&J) and SaveOnSP (a partner of Express Scripts) has put patient assistance programs in the headlines. Created as a means to promote medication affordability, drug manufacturer copay cards and their application in employer benefit designs has sparked controversy across the industry. To help clarify the confusion, in this article we explore the differences between copay accumulators and copay maximizers and the resulting impact on costs for patients, plan sponsors (employers), and pharmaceutical companies.

Copay Accumulator
In accumulator programs, drug manufacturer financial assistance is applied towards a patient’s drug cost as it is incurred throughout the year, but the financial assistance amount does not count towards the patient’s deductible or out-of-pocket (OOP) maximum. If all of the available assistance is exhausted before the end of the year, a patient’s payment portion could be higher in remaining months, until their deductible or OOP maximum is met. While plan sponsors can save money in this scenario, patient affordability concerns may lead to issues with medication refills and adherence, resulting in poorer health and financial outcomes.

Copay Maximizer
Copay maximizer programs (like SaveOnSP and PrudentRx) were developed by Pharmacy Benefit Managers (PBMs) to maximize the value of financial assistance from drug manufacturers. To do so, specialty medications are classified as “non-essential” health benefits, allowing the out-of-pocket maximums for these drugs to be capped at an amount higher than specified by the Affordable Care Act (ACA). The medications are then assigned a coinsurance percentage under the benefit design, but the actual patient responsibility is kept at $0. The maximizer program identifies the amount of financial assistance available, spreading this across the plan year (and now higher OOP max) to use the largest amount of funds possible. While each PBM’s maximizer arrangement is structured slightly differently, the end goal remains the same: optimizing medication adherence while also saving patients and plan sponsors money.

Financial Breakdown
The relative outcome for employers will be dependent on plan design and richness of coverage. Often, savings are most significant under high deductible health plans and less material under PPO plans. Nevertheless, regardless of plan type, patient affordability still improves dramatically under maximizer programs, making them a popular option. As of 2021, Drug Channels Institute estimated that 60% of plan sponsors were offering a maximizer program.

What's to Come?
Although the outcome of the J&J lawsuit and the future of patient assistance programs is unclear, these arrangements have resulted in significant savings for patients and employers. In 2021, one copay maximizer program achieved millions of dollars in savings for a subset of BHC employers participating in the Pharmacy Management Initiative, while also reducing patient out-of-pocket costs to $0. Yet, even with these positive outcomes, the root issue remains. Until life-saving medications are priced by manufacturers at more reasonable levels, copay assistance will continue to be just a temporary Band-Aid to America's drug affordability crisis.

1. Any Willing Pharmacy provision, which would require PBMs and employer-sponsored plans to include all pharmacies in their networks, thus diminishing the ability to select preferred networks for volume discounts and improved pricing.
   
   
2. Guaranteeing pharmacies reimbursement of their generic drug acquisition costs, which would remove market forces and incentives for pharmacies to be competitive in procuring drugs for the lowest cost possible.
   
   
3. State-legislated contract definitions for rebates and generics, which place restrictions on private contracts and could present roadblocks and delays in quickly modifying terms to reflect the dynamic pharmaceutical market.
   
   
4. Eliminating longstanding ERISA protections for employer plan designs in Missouri, adding administrative and compliance burden to multi-state plans and deterring the attractiveness of Missouri to potential employers.

BHC Position: Opposed (view BHC’s letter to the House Health and Mental Health Policy Committee for a full overview of talking points).

Current Status: HB 1677 passed the House Health and Mental Health Policy Committee with a 11-0 vote on February 14. The bill has since been approved the House Rules Committee with a 9-4 vote. SB 921 has been referred to the Senate Insurance Committee and has not yet received a hearing. 

Employer Action Step: Contact your Missouri House Representative and Missouri State Senator to express your concerns over the implications of these bills for employers, workers, and the community at large.

House Bill 2305
Senate Bill 1129

Key Provisions:

1. Prohibits a health carrier or pharmacy benefits manager from imposing a penalty, impediment, differentiation, or limitation on a provider, patient, or pharmacy (including hospital) for providing, dispensing, or receiving a medically necessary clinician-administered drug, regardless of in-network or out-of-network status.
   
   
2. A health carrier or pharmacy benefits manager may not discriminate, lower the reimbursement, or impose any separate contract terms upon an entity based upon that entity's participation in the 340B drug pricing program. All pharmacy claims processed by a pharmacy that participates in the 340B drug pricing program are final at the point of adjudication.
   
   
3. This bills define "biological product", "biosimilar product", and "reference product" as having the same meaning as given to the terms under federal law. A health carrier or pharmacy benefits manager that provides coverage for a reference product or biosimilar biological product must provide coverage for the reference product and all biological products that have been deemed biosimilar to the reference product.
   
   

BHC Position: Opposed. This bill would restrict “white-bagging,” a process whereby a patient’s medication can be shipped directly from a specialty pharmacy (often through the PBM) to the administering site (e.g. hospital, clinic, etc.) for a much lower price. Calls have also been made recently for more (not less) oversight of 340B pharmacies due to their ability to purchase medications at deeply discounted prices while still charging the full price to public and private insurance plans, providing up to 100% profit margins on these drugs. Finally, by mandating specific pharmacy contract definitions and formulary coverage, this bill will prevent employers and PBMs from reacting quickly to changing market forces to negotiate new terms that can benefit the plan and its covered members. 

Current Status: HB 2305 has been referred to the House Insurance Committee on February 1 and has yet to receive a hearing. SB 1129 has yet to be referred to a Committee in the Senate.

Employer Action Step: Contact your Missouri House Representative and Missouri State Senator to express your concerns over the implications of these bills for employers, workers, and the community at large.

House Bill 2165

Key Provision:

1. Modifies the definition of "telehealth" and "telemedicine" to include the use of adaptive questionnaires, making them equivalent to a physical examination for the purposes of establishing a physician-patient relationship and prescribing any drug, controlled substance, or other treatment.
   
   
2. Enables adaptive questionnaires to be billed at the same amount as an in-person office visit.
   
   

BHC Position: Opposed. While electronic surveys are a useful and convenient technology that may assist in the diagnosis or treatment process, they are not equivalent to a physical exam with a care provider and thus should be reimbursed at lower amount than an in-person visit. This legislation removes any financial savings that might accrue to plan sponsors and patients from the use of telehealth.

Current Status: HB 2165 was approved by the House Health and Mental Health Policy Committee by an 11-2 vote on February 28. The bill has been referred to the House Rules Committee.

Employer Action Step: Contact your Missouri House Representative to express your concerns over the implications of this bill for employers, workers, and the community at large.

The BHC and its lobbyist, Chris Long, continue to participate actively in legislative hearings in Jefferson City to ensure that purchaser interests are represented and that decisions do not adversely impact employers’ ability to provide high-quality, affordable benefits. We appreciate your organization’s assistance in opposing these bills and are happy to provide additional guidance as you prepare to outreach to Missouri General Assembly leaders. For questions, please contact BHC Executive Director, Louise Probst.

Opal Chaudhary, PharmD, BCGP

Academic Detailer

BHC Pharmacy Management Initiative

As the world enters the second year of the pandemic, oral antiviral medications are coming to market as a treatment option for COVID-19. With vaccine rates continuing to climb slowly across the nation, oral antiviral medications could help currently infected individuals by reducing illness severity and subsequent hospitalizations, improving the recovery process and timeline, and (importantly) providing relief to our health care systems.

Antiviral medications generally work in two ways: (1) by blocking the virus from entering host cells, or (2) by interrupting the replication of the virus. The antiviral medications that are currently available to treat COVID-19 are administered in the hospital via intravenous injection. The new oral agents will give patients an easily accessible and less invasive treatment option to improve the course of the disease. These medications will be available to patients that have mild to moderate symptoms to help prevent more severe symptoms. 

On December 22, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Pfizer's Paxlovid for the treatment of mild-to-moderate coronavirus disease in adults and pediatric patients (12 years of age and older weighing at least 88 pounds) who are at high risk for progression to severe COVID-19, including hospitalization or death. The recommended dosing is 300mg (two tablets) of Paxlovid plus one 100mg ritonavir tablet twice daily for five days. Ritonavir, a medication used to treat HIV, is added to help slow down the metabolism of Paxlovid so it stays active in the body for a longer period of time. Clinical data demonstrated an 89% reduction in the risk of COVID-19-related hospitalization or death in adults treated with Paxlovid, compared to placebo, within three days of symptom onset. President Joe Biden has purchased at least 10 million courses of treatment, with the U.S. government’s initial contracted price set at $529 per course.

On December 23, the FDA issued an EUA for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease in adults (18 years and older) who are at high risk for progression to severe COVID-19, including hospitalization or death. However, with concerns around potential birth defects (as seen in rats during early testing), the drug cannot be used in pregnant women. The recommended dosing is 800mg every 12 hours for five days. Results showed a 30% reduction in the risk of hospitalization or death compared to a placebo. The U.S. government has contracted to buy as many as 5 million courses of the treatment at a price of $700 per course.

Other manufacturers that are conducting clinical trials for oral treatment options include Atea Pharmaceuticals, Fujifilm Toyama Chemical, and Redhill Biopharma. Data has not been submitted to the FDA for emergency use authorization but may be seen by early 2022. Stay tuned for announcements on when these agents may become available to patients across the country.

The BHC will be active in representing employer interests on a number of health-related issues. BHC will oppose legislative efforts to weaken the role of employers or pharmacy benefit managers (PBMs) in helping to control prescription drug costs. A pair of 2022 bills have been filed to enact pharmacy any willing provider statutes in Missouri, and recent court decisions have ruled similar statutes in other states can apply to ERISA employer plans. The BHC helped to defeat a similar proposal last session. The BHC will also oppose bills that would impose on employers’ plan design or weaken the use of step therapy protocols.

The BHC supports expansion of the state’s Medicaid system. Voters approved expansion by overwhelmingly passing Amendment 2 in 2020. A pair of court rulings have declared the measure constitutional and have ordered implementation of the expansion. However, the Missouri legislature failed to appropriate funding for the program in the 2021 session. In keeping with the public vote and court rulings, an attempt will be made to pass a funding vehicle, despite continued opposition to expansion from certain members of the legislature.

Pre-filed 2022 bills also include measures to repeal the Prescription Drug Monitoring Program (PDMP), which was passed in 2021 after years of debate. Multiple bills have also been introduced to repeal the state’s Certificate of Need program. BHC supports both of these programs and will actively oppose their repeal. We will also continue our opposition to ongoing legislative attempts to mandate costly benefits onto employer-sponsored plans.

If you are interested in getting more involved in state or national health policy discussions and advocacy, please contact Kitrina Miller, BHC Administrative Associate. 

The FRA is normally renewed each session without controversy.  But, the Legislature failed to pass a funding measure during the 2021 regular session when an unsuccessful attempt was made to leverage the FRA renewal to block funding for Planned Parenthood. A similar failed attempt was made during the special session.

Governor Mike Parson had threatened $722 million in budget cuts if the House and Senate did not pass the FRA extension prior to the July 1 beginning of the state’s fiscal year. The Governor signed the FRA extension on June 30.

State Supreme Court to Hear Medicaid Expansion Arguments

During the 2021 session, the Missouri Legislature refused to provide funding for a BHC-supported, voter-approved Medicaid expansion measure which was scheduled to go into effect July 1.

On June 23, the Cole County Circuit Court (Jefferson City) ruled that Amendment 2, which expanded Medicaid to adults age 19 to 65 whose income is less than 133 percent of the federal poverty level, was unconstitutional.  The ruling by Judge Jon Beetem said Amendment 2 didn’t provide a way for the state to pay for the expansion.

The Cole County Circuit ruling has been appealed to the Missouri Supreme Court and oral arguments in the case are scheduled for July 13.