Specialty Pharmacy

News Briefs

August 4, 2021

Bristol Myers Squibb will voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib. The move follows an April meeting of the agency’s Oncologic Drugs Advisory Committee to discuss whether to keep certain indications for a handful of checkpoint inhibitors that target programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) and received accelerated approval but had not met post-marketing requirements demonstrating confirmatory benefit. Opdivo received a negative vote for this indication, as did Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with disease progression on or after at least two lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2/neu-targeted therapy. Merck said recently that it would voluntarily withdraw that indication in the U.S.

Bristol Myers Squibb will voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib. The move follows an April meeting of the agency’s Oncologic Drugs Advisory Committee to discuss whether to keep certain indications for a handful of checkpoint inhibitors that target programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) and received accelerated approval but had not met post-marketing requirements demonstrating confirmatory benefit. Opdivo received a negative vote for this indication, as did Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with disease progression on or after at least two lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2/neu-targeted therapy. Merck said recently that it would voluntarily withdraw that indication in the U.S.

Bristol Myers Squibb also will withdraw the indication for Istodax (romidepsin) as monotherapy for the treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy. The FDA initially gave the drug from Celgene Corp., now a Bristol Myers Squibb subsidiary, accelerated approval. A confirmatory Phase III trial did not meet the primary efficacy endpoint of progression free survival.

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Offering Patients Money to Switch Drugs May Become PBM Tool

July 8, 2021

PBMs have used formulary exclusions as an effective way to negotiate with manufacturers for several years. However, at least one payer has gotten more aggressive with its tactics to get members to move from an excluded drug to one with preferred status, dangling a financial incentive for members. That effort is facing pushback from several medical associations, but if it proves to be successful, other companies could follow suit, suggest industry experts.

PBMs began implementing formulary exclusion lists about 10 years ago, and specialty drugs have made up an increasing number of the excluded products. As of early 2021, each of the Big Three — CVS Health’s Caremark, Cigna’s Express Scripts and UnitedHealth Group’s OptumRx — was excluding more than 400 products.

PBMs have used formulary exclusions as an effective way to negotiate with manufacturers for several years. However, at least one payer has gotten more aggressive with its tactics to get members to move from an excluded drug to one with preferred status, dangling a financial incentive for members. That effort is facing pushback from several medical associations, but if it proves to be successful, other companies could follow suit, suggest industry experts.

PBMs began implementing formulary exclusion lists about 10 years ago, and specialty drugs have made up an increasing number of the excluded products. As of early 2021, each of the Big Three — CVS Health’s Caremark, Cigna’s Express Scripts and UnitedHealth Group’s OptumRx — was excluding more than 400 products.

Earlier this year, Cigna began offering people on Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) a $500 debit card if they switched from that agent — which moved from preferred to excluded status on Jan. 1 — to one of its preferred inflammatory treatments. Cosentyx is a human interleukin-17A antagonist approved for adult and pediatric plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The company also has a nonpreferred formulary tier.

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Prime Rolls Out New Medical Benefit Management Offering

July 8, 2021

As payers continue to look for ways to tackle the rising spending on specialty drugs, Prime Therapeutics LLC is launching a medical drug management program. Known as MedDrive, the offering will be rolled out in phases, with the initial one focused on increasing the use of biosimilars.

Last year, specialty drugs made up more than half of total drug spending for the first time. That trend shows no signs of slowing, as the pharmaceutical pipeline is full of specialty agents, including biosimilars. As of early July 2021, the FDA has approved 29 biosimilars, although not all have launched due to patent litigation. An IQVIA report published in September 2020 estimated that these products could decrease drug costs by $100 billion by 2024.

As payers continue to look for ways to tackle the rising spending on specialty drugs, Prime Therapeutics LLC is launching a medical drug management program. Known as MedDrive, the offering will be rolled out in phases, with the initial one focused on increasing the use of biosimilars.

Last year, specialty drugs made up more than half of total drug spending for the first time. That trend shows no signs of slowing, as the pharmaceutical pipeline is full of specialty agents, including biosimilars. As of early July 2021, the FDA has approved 29 biosimilars, although not all have launched due to patent litigation. An IQVIA report published in September 2020 estimated that these products could decrease drug costs by $100 billion by 2024.

In April, Prime released a white paper on biosimilars indicating that the company “will actively promote the evidence-based use of biosimilars (and other low-cost drug options),” a position endorsed by the company’s pharmacy and therapeutics (P&T) committee. Prime is collectively owned by 19 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of those plans; the PBM serves nearly 33 million people across 23 Blues plans. The P&T committee is made up of independent, practicing physicians and pharmacists who cover 25 medical and pharmacy specialties, as well as senior leadership from Prime’s Blues plans.

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Zeposia May Have Challenges Within Ulcerative Colitis Class

Chart: Anticipated Prescribing of Zeposia in Ulcerative Colitis Assuming FDA Approval

July 8, 2021

A recently approved product in the ulcerative colitis therapeutic class brings a new mechanism of action. However, according to payers responding to a survey by Zitter Insights, the treatment — Bristol Myers Squibb’s Zeposia (ozanimod) — may have some challenges breaking into the space.

On May 27, the FDA gave an additional indication to Zeposia for the treatment of adults with moderately to severely active ulcerative colitis. It is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for this indication. The agency initially approved the capsule on March 26, 2020, for relapsing forms of multiple sclerosis (MS). Three other oral S1Ps are approved for MS: Gilenya (fingolimod) and Mayzent (siponimod), both from Novartis Pharmaceuticals Corp., and new entrant Ponvory (ponesimod), from the Janssen Pharmaceutical Companies of Johnson & Johnson.

A recently approved product in the ulcerative colitis therapeutic class brings a new mechanism of action. However, according to payers responding to a survey by Zitter Insights, the treatment — Bristol Myers Squibb’s Zeposia (ozanimod) — may have some challenges breaking into the space.

On May 27, the FDA gave an additional indication to Zeposia for the treatment of adults with moderately to severely active ulcerative colitis. It is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for this indication. The agency initially approved the capsule on March 26, 2020, for relapsing forms of multiple sclerosis (MS). Three other oral S1Ps are approved for MS: Gilenya (fingolimod) and Mayzent (siponimod), both from Novartis Pharmaceuticals Corp., and new entrant Ponvory (ponesimod), from the Janssen Pharmaceutical Companies of Johnson & Johnson.

Treatment is initiated with a 0.23 mg dose once daily on days one through four, then 0.46 mg once daily on days five through seven and then 0.92 mg once daily afterwards. The price of a starter kit consisting of the initial 37-day supply is $9,110, and a 30-day supply is $7,387 for an annual wholesale acquisition cost of just under $90,000. Both indications are priced the same.

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Employers Have Variety of Approaches for High-Cost Drugs

July 8, 2021

As more high-cost drugs, including one-time gene therapies, come onto the market, employers are considering implementing a variety of contracting models to make sure their employees have access to these agents. However, even as innovative new approaches are being explored, employers have experienced challenges in executing them. But with the pharma pipeline full of specialty products, employers should explore which approaches may work best for their company.

“The emerging financial models for employers stemming from these new ultra–high-cost gene therapies include various reinsurance products from organizations like Cigna, CVS/Aetna, Prime Therapeutics and others,” explains Jorge Font, MPH, senior vice president of the access experience team at PRECISIONvalue. “These products involve a regular per-member-per-month premium paid to cover the risk of these low-frequency, high-cost claims.”

As more high-cost drugs, including one-time gene therapies, come onto the market, employers are considering implementing a variety of contracting models to make sure their employees have access to these agents. However, even as innovative new approaches are being explored, employers have experienced challenges in executing them. But with the pharma pipeline full of specialty products, employers should explore which approaches may work best for their company.

“The emerging financial models for employers stemming from these new ultra–high-cost gene therapies include various reinsurance products from organizations like Cigna, CVS/Aetna, Prime Therapeutics and others,” explains Jorge Font, MPH, senior vice president of the access experience team at PRECISIONvalue. “These products involve a regular per-member-per-month premium paid to cover the risk of these low-frequency, high-cost claims.”

Reinsurance Does Not Have Big Uptake

This approach, he says, is similar conceptually to regular reinsurance, also known as stop-loss coverage, for high-cost claims. “Jumbo-sized self-insured employers (like insurance companies) may not require reinsurance since they have sufficient enrollment to spread the risk. Provided a decision is made to cover gene therapy, employers can decide how best to handle the risk. Employers must typically opt in to coverage, much like an optional rider. These programs may also feature value-based contract terms, with the manufacturer sharing all or part of the risk of failed treatment. At this time, there does not appear to be significant uptake in these commercial reinsurance programs given the lack of clarity on gene therapy cost/benefit and the more immediate focus by employers on the COVID-19 pandemic.”

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New FDA Specialty Approvals

July 8, 2021

June 7: The FDA granted another indication to Alexion Pharmaceuticals, Inc.’s Ultomiris (ravulizumab-cwvz) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in children at least 1 month old and adolescents. It is the only PNH therapy approved for use in these age groups. The agency initially approved the C5 inhibitor on Dec. 21, 2019, for PNH in adults. Dosing is weight-based; administration intervals also are weight-based and are either every four weeks or every eight weeks. The estimated average cost per year in adults is $458,000.

June 7: The FDA granted another indication to Alexion Pharmaceuticals, Inc.’s Ultomiris (ravulizumab-cwvz) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in children at least 1 month old and adolescents. It is the only PNH therapy approved for use in these age groups. The agency initially approved the C5 inhibitor on Dec. 21, 2019, for PNH in adults. Dosing is weight-based; administration intervals also are weight-based and are either every four weeks or every eight weeks. The estimated average cost per year in adults is $458,000.

June 9: The FDA gave another indication to Vertex Pharmaceuticals Inc.’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis who are 6 to 11 years old and have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data. The agency also approved a new dosage strength of the tablet: elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg and ivacaftor 75 mg. The FDA first approved the drug on Oct. 21, 2019. Dosing in this new age group for people less than 30 kg is two elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg tablets in the morning and one ivacaftor 75 mg tablet in the evening. For those weighing at least 30 kg, dosing is two elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg tablets in the morning and one ivacaftor 150 mg tablet in the evening. Website Drugs.com lists the price of 84 tablets of the latter dose as more than $24,900.

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