Preview: RADAR on Specialty Pharmacy

New FDA Specialty Approvals

June 10, 2021

May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma. The agency gave the application priority review, and the review was conducted through the Real-Time Oncology Review (RTOR) pilot program. The FDA first approved the programmed cell death-1 (PD-1) inhibitor on Sept. 4, 2014. The recommended dose of Keytruda is 200 mg every three weeks or 400 mg every six weeks via a 30-minute intravenous infusion. The list price for the every-three-weeks dosing is $9,869.94; for every six weeks, it’s $19,739.88.

May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma. The agency gave the application priority review, and the review was conducted through the Real-Time Oncology Review (RTOR) pilot program. The FDA first approved the programmed cell death-1 (PD-1) inhibitor on Sept. 4, 2014. The recommended dose of Keytruda is 200 mg every three weeks or 400 mg every six weeks via a 30-minute intravenous infusion. The list price for the every-three-weeks dosing is $9,869.94; for every six weeks, it’s $19,739.88.

May 14: The FDA approved Apellis Pharmaceuticals, Inc.’s Empaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) who are treatment naïve, as well as people switching from any C5 inhibitors, including Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz). Empaveli is the first C3 inhibitor for PNH. The agency gave the drug priority review, as well as fast track and orphan drug designations. The recommended dose is 1,080 mg twice weekly via subcutaneous infusion using an infusion pump. The drug’s annual wholesale acquisition cost is $458,000.

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News Briefs

June 10, 2021

The U.S. Supreme Court denied a petition from Novartis AG’s Sandoz unit to review the 2020 Federal Circuit decision to uphold two patents of Amgen Inc.’s Enbrel (etanercept). The FDA approved Sandoz’s Enbrel biosimilar, which is known as Erelzi (etanercept-szzs), on Aug. 30, 2016, but the Supreme Court’s decision means Enbrel biosimilars will not be able to launch until 2029. The FDA approved another Enbrel biosimilar, Samsung Bioepis Co., Ltd.’s Eticovo (etanercept-ykro), on April 25, 2019. Novartis says that estimates indicate that a biosimilar of Enbrel could save the U.S. health care system around $1 billion per year.

The U.S. Supreme Court denied a petition from Novartis AG’s Sandoz unit to review the 2020 Federal Circuit decision to uphold two patents of Amgen Inc.’s Enbrel (etanercept). The FDA approved Sandoz’s Enbrel biosimilar, which is known as Erelzi (etanercept-szzs), on Aug. 30, 2016, but the Supreme Court’s decision means Enbrel biosimilars will not be able to launch until 2029. The FDA approved another Enbrel biosimilar, Samsung Bioepis Co., Ltd.’s Eticovo (etanercept-ykro), on April 25, 2019. Novartis says that estimates indicate that a biosimilar of Enbrel could save the U.S. health care system around $1 billion per year.

Viatris Inc. expects the FDA to approve two of its insulin products as interchangeable biosimilars this summer, the company said during its May 10 conference call to report first-quarter 2021 earnings. The company — formed in 2020 through the combination of Mylan N.V. and Pfizer’s Upjohn business — said its insulin glargine, whose reference drug is Sanofi’s Toujeo, and insulin aspart, whose reference drug is Novo Nordisk’s NovoLog/NovoRapid, are on track to be approved as interchangeable in July. As of early June, the FDA has approved 29 biosimilars, but none have the interchangeable designation. Insulins became eligible for biosimilar status when the FDA transitioned certain protein products approved under the Federal Food, Drug, and Cosmetic Act to the Public Health Service Act on March 23, 2020.

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Pilot Program Targets SDOH Barriers for Members With MS

May 6, 2021

Recently, health insurers have begun focusing on social determinants of health (SDOH) and the role these factors play on health outcomes. Then the COVID-19 pandemic put even more of a spotlight on the issue, disproportionately affecting people of color and low-income communities. Recognizing the impact that SDOH can have, AllianceRx Walgreens Prime is partnering with Highmark Inc. to launch a pilot outreach program focused on the impact of SDOH on people with multiple sclerosis (MS).

According to the Healthy People 2030 initiative from HHS’s Office of Disease Prevention and Health Promotion, SDOH “are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” These include financial strain, transportation needs, food insecurity and housing instability.

Recently, health insurers have begun focusing on social determinants of health (SDOH) and the role these factors play on health outcomes. Then the COVID-19 pandemic put even more of a spotlight on the issue, disproportionately affecting people of color and low-income communities. Recognizing the impact that SDOH can have, AllianceRx Walgreens Prime is partnering with Highmark Inc. to launch a pilot outreach program focused on the impact of SDOH on people with multiple sclerosis (MS).

According to the Healthy People 2030 initiative from HHS’s Office of Disease Prevention and Health Promotion, SDOH “are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” These include financial strain, transportation needs, food insecurity and housing instability.

The program will apply to Highmark members with an MS diagnosis who use AllianceRx Walgreens Prime as their specialty pharmacy. To participate, these members must be willing to take part in a 13-question, voluntary survey conducted via telephone. SDOH-trained nurses from AllianceRx Walgreens Prime are contacting eligible members by phone and offering to administer the survey. Highmark will assess the survey responses to identify how it can design a specific care plan for each member facing SDOH challenges.

The pilot will determine the success rate of a specialty pharmacy in administering the survey and the ability to address any member issues.

“Based on the self-identified needs of the member, the Highmark Social Work team will outreach to further assess the SDOH issue or barriers,” explains Amy Shannon, director of health and wellbeing integration at Highmark. “In partnership with the member, our social worker will identify available resources to assist in reducing or eliminating the barrier.”

The outreach, she says, “is the first step to help ensure members who are already facing health challenges have the support and resources they need to overcome barriers in other aspects of their lives which impact their health. By reducing or eliminating these barriers, people are free to be their best.”

“This pilot demonstrates the continual evolution of patient care and collaborative efforts between key stakeholders,” says Nebeyou Abebe, senior vice president of social determinants of health for Highmark. “Highmark recognizes that to understand and impact health, we must consider the physical, mental and social health of our members. Understanding, identifying and addressing SDOH factors that MS patients experience is a further commitment to improving their treatment journey and overall outcomes.”

“SDOH can drive up to 80% of an individual’s health outcomes,” Shannon says. “It’s imperative that we assess and provide support to members who are facing SDOH issues.”

The nurses began making phone calls on April 19. Since then, AllianceRx Walgreens Prime already has identified some SDOH barriers among Highmark members, says Rick Miller, BS.Pharm., MS.Pharm., vice president of clinical and professional services at AllianceRx Walgreens Prime.

The pilot is focusing on seven domains, he explains: “social connections, financial resource strain, health literacy, food insecurity, transportation needs, safety and housing stability. While these SDOH domains may impact any patient with a health condition, in the short time the pilot has been live, we have already identified transportation needs, housing stability and financial resource strain as concerns within the MS population.”

Companies Have Worked Together Before

Miller notes that AllianceRx Walgreens Prime and Highmark have worked together on “several innovative programs to support Highmark members receiving specialty medications, focusing on improving the quality of patient care, as well as addressing the overall cost of health care. The SDOH pilot was a project on which both organizations enthusiastically aligned as an area of focus.”

According to Shannon, “since November 2019, Highmark has used a standardized SDOH survey to assess for barriers that health plan members may be facing.” More than 50,000 Highmark members have completed it.

As far as starting the program with a focus on MS, Miller says that both AllianceRx Walgreens Prime and Highmark already had “dedicated clinical and operational teams to support the MS patient population. With that infrastructure already in place, we selected MS as the initial disease state to pilot the SDOH survey process.”

Miller explains that some metrics that will be tracked to measure the pilot’s success include:

“The number of Highmark members eligible for outreach by AllianceRx Walgreens Prime;

“The number of Highmark members outreached by AllianceRx Walgreens Prime and the disposition of each outreach (e.g., could not reach, left voicemail, etc.);

“The number of completed surveys;

“The number of Highmark members identified by AllianceRx Walgreens Prime as having an urgent member need(s) and referred to Highmark through an escalation process for immediate action; and

“Of completed surveys with identified SDOH concerns, how many Highmark members received support services.”

While the survey is offered by telephone only at this time, Miller says that “other communication and technology options are being explored. Based upon the success of the pilot, these additional options may be considered for future development,” such as digital-based solutions.

The program will run for one year. Depending on its success, additional patient populations may be included in future phases. “We are exploring a number of specialty disease states for future expansion,” Miller tells AIS Health, a division of MMIT. “Initial expansion would focus on chronic specialty therapies, as well as specialty disease states, such as oncology and autoimmune diseases, that can be complex and challenging for patients to navigate through the health care system.”

“Both companies are optimistic about the future of this program,” says Miller. “The opportunity for improving the quality of life among people with rare and chronic conditions is why we do what we do and is professionally rewarding for all those involved. It also underscores the importance AllianceRx Walgreens Prime places on innovation and collaboration with partners like Highmark.”

Contact Abebe and Shannon through Emily Beatty at emily.beatty@highmarkhealth.org and Miller through Adrienne Foley at Adrienne.foley1@alliancerxwp.com.

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Study Finds Wide Variation in Payers’ CAR-T Drug Costs

May 6, 2021

Chimeric antigen receptor T cell (CAR-T) therapies have been available in the U.S. since August 2017. While the list prices for the one-time treatments are known, a recent study from Prime Therapeutics LLC examined their total cost of care and clinical events following administration and found that payer costs for the therapies varied widely. Payers could use this information to help forecast costs for these drugs and strike value-based deals, says one author of the study, which was presented at the Academy of Managed Care Pharmacy’s AMCP 2021 virtual conference in April.

Chimeric antigen receptor T cell (CAR-T) therapies have been available in the U.S. since August 2017. While the list prices for the one-time treatments are known, a recent study from Prime Therapeutics LLC examined their total cost of care and clinical events following administration and found that payer costs for the therapies varied widely. Payers could use this information to help forecast costs for these drugs and strike value-based deals, says one author of the study, which was presented at the Academy of Managed Care Pharmacy’s AMCP 2021 virtual conference in April.

Study Examined First Two CAR-Ts

Researchers examined the first two CAR-Ts on the U.S. market. Yescarta (axicabtagene ciloleucel) from Kite Pharma, Inc., a Gilead Sciences, Inc. company, was approved Oct. 18, 2017, for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy (RSP 11/17, p. 8). The drug — which gained FDA approval for relapsed or refractory follicular lymphoma after at least two forms of treatment on March 6 (RSP 4/21, p. 8) — is priced at $373,000.

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Precision Oncology Solution Aims to Improve Patient Outcomes

May 6, 2021

With more and more oncolytics targeting specific alterations in tumors, the area of precision oncology is developing rapidly. To help bring some insight into this market, Magellan Rx Management, a division of Magellan Health, Inc., and Trapelo Health, a wholly owned subsidiary of NeoGenomics Bioinformatics, recently unveiled a collaboration aimed at helping both providers and payers navigate this complex space and ultimately improve patient outcomes.

With more and more oncolytics targeting specific alterations in tumors, the area of precision oncology is developing rapidly. To help bring some insight into this market, Magellan Rx Management, a division of Magellan Health, Inc., and Trapelo Health, a wholly owned subsidiary of NeoGenomics Bioinformatics, recently unveiled a collaboration aimed at helping both providers and payers navigate this complex space and ultimately improve patient outcomes.

The offering combines Magellan Rx’s comprehensive oncology management solution and Trapelo’s precision-medicine platform, which provides fast, accurate testing and treatment decision support. Trapelo links providers, laboratories and payers by providing access to molecular testing information, allowing providers to order tests from preferred labs and interpreting those results, including identifying appropriate, evidence-based treatments. It offers automated prior authorization, incorporates health plan policies and eliminates unneeded medical redocumentation. These services will support Magellan Rx’s medical pharmacy program, which addresses various aspects of cancer care such as guideline-supported prior authorization, drug waste, personalized dosing, oral oncology management, post-service claim edits and provider network management.

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