Paxlovid, Molnupiravir Access Threatened By ‘Dismal' Pharmacy Dispensing Fees, CMS Told
Executive Summary
Pharmacy organization urges the Centers for Medicare and Medicaid Services to recommend a dispensing fee commensurate with the effort involved in filling scripts for the drugs.
COVID-19 oral antivirals from Pfizer Inc. and Merck & Co., Inc. may face access restrictions because health plans and pharmacy benefit managers are providing dispensing fees that many pharmacies believe are inadequate to cover costs.
Pfizer’s Paxlovid (nirmatrelvir/ritonavir) and Merck’s molnupiravir were approved under US Food and Drug Administration emergency use authorizations in late December as oral treatments for patients with mild to moderate COVID-19 who are at high risk for progressing to severe disease. (Also see "Merck’s Molnupiravir: Second COVID Pill Is Second-Line, But Timing Helps Both Sponsor And US FDA" - Pink Sheet, 23 Dec, 2021.)
The drugs are being distributed to pharmacies for free under purchasing agreements between the manufacturers and the US government. (Also see "Pfizer Getting $529 Per Course For Paxlovid Under US Contract; Did Merck Drive A Harder Bargain?" - Pink Sheet, 19 Nov, 2021.)
Supply is expected to be very limited in the near term and ramp up later in 2022. Initial shipments of the drugs included just 300,000 courses of molnupiravir and 65,000 courses of Paxlovid, according to the Department of Health and Human Services.
Nevertheless, for pharmacists the launch has already been a challenge. “At the end of the first distribution cycle, pharmacy owners … find themselves blinking in disbelief at the dispensing fees that are supposed to cover the costs involved in dispensing US government procured Paxlovid and molnupiravir,” the National Community Pharmacy Association said in an 18 January letter to the Centers for Medicare and Medicaid Services.
As a result, NCPA “asks for immediate intervention before these pharmacies are forced to stop dispensing the oral antiviral drugs because they can’t justify the cost to their business,” the letter states.
“This is becoming an impediment to the successful rollout of these products,” NCPA senior VP of strategic initiatives Kurt Proctor told the Pink Sheet. The association is hoping that if CMS provides guidance for higher dispensing fees in Medicare and Medicaid, that the commercial market will follow suit, he added.
"This is becoming an impediment to the successful rollout of these products," NCPA senior VP Kurt Proctor says.
The reimbursement rates that NCPA members have reported may be higher than the usual negotiated dispensing fees, the letter notes. However, “they are still far below these pharmacies’ cost to dispense,” the group maintained. The highest dispensing fee received to date was $10.50 and the lowest was $1 and provided by the BlueCross BlueShield pharmacy benefit manager Prime Therapeutics, the association said.
Even the $10.50 dispensing fee “fails to cover the additional costs required to optimize beneficiary safety and effectiveness for these breakthrough treatments,” the group argued. “This is astounding and extremely disappointing considering the US government has paid over $700 per course of therapy for molnupiravir and over $500 per course of therapy for Paxlovid.”
Dispensing Is Labor Intensive, Especially for Paxlovid
Pharmacies in the first distribution cycle estimate the additional time involved with dispensing the oral antivirals requires a dispensing fee consistent with the COVID-19 vaccine administration fee of $40, the letter says.
“This reflects additional steps such as the non-standard ordering and receiving of the physical product, on-boarding new patients, and participating in the prescriber decision making process” which includes working with prescribers to prioritize limited available doses, collecting accurate data on e-prescriptions and transitioning patients from monoclonal antibodies to oral therapy.
The letter provides a list of extra steps that must be taken that can add up to about 40 minutes per script. Paxlovid, in particular, requires extra attention because “prescribers are not up to speed on all the interactions, co-morbidity issues, dose adjustment for renal impairment, etc.” that is required for the drug. As a result, pharmacists are “having to interact with prescribers for every potential Paxlovid patient,” the letter notes.
Both drugs have potential side effects and unique safety considerations for certain populations, but Paxlovid interacts with other medicines that are fairly commonly used. Paxlovid is also not recommended for patients with severe kidney problems or patients with cirrhosis of the liver.