Radar on Specialty Pharmacy

Years of advances in driving down cancer occurrences and deaths could be completely reversed by the COVID-19 pandemic. A recently published study shows screenings, diagnoses and treatment for various cancers dropped dramatically from March through July when compared with 2019 rates.

Researchers analyzed 6,227,474 claims from a provider clearinghouse representing 5% to 7% of the Medicare fee-for-service population. In April, at the height of the pandemic, screening for breast cancer was down by 85%; screening for colon cancer dropped by 75%; prostate cancer screening declined by 74%; and lung cancer screening was down by 56%. Hospital outpatient Evaluation and Management visits dropped 74% in April; new patient E&M visits fell 70%, and existing patient E&M visits declined 60%.

The United States is seeing a surge of innovative specialty therapeutics coming onto the market, many of which offer potential treatments for conditions that previously didn’t have one. But many of these newer therapies are launching with expensive price tags, driving up spending on health care services. A Prime Therapeutics LLC study found a huge increase in people who have annual drug spend of at least $250,000 — so-called “drug super spenders”— from 2016 to 2019.

Researchers analyzed pharmacy and medical benefit claims from a commercially insured population of 17.9 million members between January 2016 and December 2019. They defined “cost” as plan and member cost share after network discounts but did not include manufacturer rebates or coupons. For drug super spenders, researchers used diagnosis codes to determine a clinical condition category based on their drug use.

A recent study of Anthem’s Cancer Care Quality Program (CCQP) treatment pathways found that an enhanced reimbursement to providers who adhere to on-pathway treatment regimens increased use of the drugs without changing the total care spending, supporting the payer’s efforts to move the needle on value-based care. That program has since led to the insurer’s launch of an oncology medical home this summer.

Anthem launched CCQP in 2014, rolling it out to 14 states through the next year (RSP 6/14, p. 3). Administered by the plan’s AIM Specialty Health subsidiary, the voluntary program provides enhanced reimbursement of $350 for a person’s initial on-pathway treatment and then $350 every month after for a maximum number of months as specified by CCQP. Those payments are in addition to reimbursement for office visits and drugs. There’s no penalty if a provider chooses an off-pathway regimen.

✦ Oct. 7: The FDA expanded the label of BioMarin Pharmaceutical Inc.’s Palynziq (pegvaliase-pqpz) to increase the maximum allowable dose to 60 mg for the treatment of adults with phenylketonuria. The agency initially approved the drug with a maximum dose of 40 mg on May 24, 2018 (RSP 6/18, p. 8). The recommended initial dosing of the phenylalanine (Phe)-metabolizing enzyme is 2.5 mg subcutaneously once weekly for four weeks. Then dosage should be titrated in a stepwise manner over at least five weeks to achieve a dosage of 20 mg once daily. That can be increased to 40 mg once daily after 24 weeks in people who have not achieved blood Phe control. Dosing can be increased to 60 mg once daily in people who have been on the 40 mg dose for at least 16 weeks and not achieved blood Phe control. Website Drugs.com lists the price of one syringe for all three doses — 2.5 mg/0.5 mL, 10 mg/0.5 mL and 20 mg/mL — as $541.94. Visit www.palynziq.com.

✦ Oct. 14: The FDA gave another approval to Harmony Biosciences Holdings, Inc.’s Wakix (pitolisant) for the treatment of cataplexy in adults with narcolepsy. The agency initially approved the selective histamine 3 (H3) receptor antagonist/inverse agonist on Aug. 15, 2019 (RSP 9/19, p. 8). Dosing in the first week is initiated with 8.9 mg once daily, then increased to 17.8 mg once daily in the second week and then increased to the maximum recommended dosage of 35.6 mg once daily in the third week. Website GoodRx lists the price of 60 17.8 mg tablets as more than $11,223. Visit https://wakix.com.

✦ Teva Pharmaceuticals USA, Inc. launched the first generics of Gilead Sciences, Inc.’s Truvada (emtricitabine/tenofovir disoproxil fumarate) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate). Emtricitabine/tenofovir disoproxil fumarate is indicated for the treatment of HIV-1 in combination with other antiretroviral agents in people weighing at least 37 pounds, as well as for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk people weighing at least 77 pounds. Efavirenz/emtricitabine/tenofovir disoproxil fumarate is indicated for the treatment of HIV-1 infection in people weighing at least 88 pounds either as a complete regimen or in combination with other antiretroviral agents. The wholesale acquisition cost for a tablet of 200 mg/300 mg emtricitabine/tenofovir disoproxil fumarate is $48.51 — or $1,455.30 for 30 days — and 600 mg/200 mg/300 mg efavirenz/emtricitabine/tenofovir disoproxil fumarate’s WAC is $78.86 per tablet, or $2,365.80 for 30 days. Website Drugs.com lists the price of 30 tablets of all four dosages of Truvada as $1,932.84, and the price of 30 600 mg/200 mg/300 mg tablets of Atripla as $3,135.98. Teva has savings cards for both drugs for eligible commercially insured patients available for download; the offers expire March 29, 2021. Visit www.tevahivgenerics.com.

✦ The United States realized $2.2 billion in savings from biosimilar use in 2019, according to the Association for Accessible Medicines report Securing Our Access & Savings: 2020 Generic Drug & Biosimilars Access & Savings in the U.S. Report. The total savings from 2010 to 2019 was almost $4.5 billion. But with 28 biosimilars approved and only 17 on the market, those delayed launches have cost the U.S. health system $9.8 billion in lost savings since 2015, according to the report, which was published Sept. 29. Download it at https://accessiblemeds.org/2020-Access-Savings-Report.