RADAR on Specialty Pharmacy

Do Pharma/PBM Contracts Play Role in Drugmakers’ Revenue Leakage?

Pharma manufacturers depend on contracts with PBMs — and, increasingly, their group purchasing organizations (GPOs) — to ensure favorable formulary positioning with PBMs’ health plan and employer clients. But as those contracts have grown more complex and less transparent, drugmakers may be at risk of losing significant amounts of money, according to some industry experts.

Revenue leakage — unintended revenue loss because of process inefficiencies — can be a huge financial drain on pharma manufacturers. It also may potentially result in compliance risks with the Anti-Kickback Statute and its discount safe harbor protections, “so it always has to be clearly defined as to what the rebate or any monies between pharma and the PBM being exchanged; there has to be a reason,” explains Stephanie Seadler, vice president of Trade Relations at EmsanaRx.

Novartis’ Pluvicto Brings New Mechanism of Action to mCRPC Options

A new prostate cancer drug is sparking interest among payers and oncologists alike, according to a survey by Zitter Insights. While the product offers a new mechanism of action for the indication, the manufacturer recently halted production of the therapy temporarily in two of its three global sites “out of an abundance of caution” due to “potential quality issues” that could pose a glitch in initial uptake of the therapy.

On March 23, the FDA approved Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in people who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The product from Novartis unit Advanced Accelerator Applications USA, Inc. is the first FDA-approved targeted radioligand therapy for eligible people with mCRPC that combines a targeting compound with a therapeutic radioisotope.

Study Finds PBC Drug’s Real-World, Trial Side Effects Are Similar

A recent study of a new drug to treat primary biliary cholangitis (PBC) found that common symptoms experienced by real-world patients were similar to those experienced by people in clinical trials for the agent.

PBC is a chronic disease that causes the liver’s small bile ducts to be destroyed, resulting in permanent liver damage and putting people at risk for liver failure and death. There is no cure for PBC, and the goal of treatment is to slow progression of the condition and manage its symptoms, which most commonly are itching, also known as pruritis, and fatigue.

New FDA Approvals: The FDA Granted an Additional Indication to Lynparza

April 13: The FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions: (1) first- or second-line treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy; (2) second-line treatment of metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy in people who have progressed on a first-line bevacizumab product; (3) first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) recurrent glioblastoma in adults; (5) metastatic renal cell carcinoma in combination with interferon alfa; (6) persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan; and (7) epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease in people receiving no more than two prior chemotherapy regimens. The vascular endothelial growth factor inhibitor is the third biosimilar of Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab) that the agency has approved. Dosing of the intravenous infusion is based on indication.

News Briefs: TG Therapeutics Withdraws Pending Applications for Ublituximab/Ukoniq Combo

TG Therapeutics, Inc. said April 15 that it voluntarily withdrew its pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib) for the treatment of adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma. The company said it made the decision based on updated overall survival data from the UNITY-CLL Phase III trial. The company also said that it voluntarily withdrew Ukoniq from sale for two indications: (1) for adults with marginal zone lymphoma who have received at least one anti-CD20-based regimen, and (2) for adults with follicular lymphoma who have received at least three prior systemic therapies. The FDA gave the drug accelerated approval for those indications on Feb. 5, 2021. On Feb. 3, 2022, the company disclosed that the FDA was investigating a possible increased risk of death with Ukoniq based on initial findings from the UNITY clinical trial. The FDA had scheduled an April 22 meeting to discuss the sNDA for the combination therapy, as well as Ukoniq’s accelerated approvals. Following TG Therapeutics’ withdrawal of the BLA/sNDA and Ukoniq’s existing indications, the agency cancelled the meeting. The FDA is expected to make a decision on the BLA for ublituximab in relapsing forms of multiple sclerosis by Sept. 28, 2022.

A Look at Third-Party Oncology Clinical Pathways

In order to improve patient outcomes and reduce variations in oncology care, more and more payers and providers are adopting oncology clinical pathways (OCPs) — treatment protocols that aim to provide the optimal cancer care to patients at the lowest cost, according to a recent MMIT webinar. The share of oncologists exposed to third-party oncology pathways increased from 20% in 2015 to 52% in 2021, with one third of oncologists choosing a provider-focused pathway as of the fourth quarter of 2021. Breast cancer, multiple myeloma and non-small cell lung cancer are among the top therapeutic areas managed by third-party pathways.

CMS Targets Patient-Assistance Programs; Rule Could Curtail Aid

CMS’s stance has long been that manufacturer-provided assistance given to patients is excluded from Best Price and average manufacturer price (AMP) calculation for prescription drugs. However, the rise of copayment accumulators and maximizers and health insurers’ subsequent taking of this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums have caused the agency to rethink its position. A rule slated to take effect at the beginning of 2023 would reverse that longtime approach, potentially resulting in increased patient out-of-pocket costs for drugs and pharma companies being on the hook for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ Best Price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

Carvykti Approval Brings Second CAR-T to Multiple Myeloma Treatment

With its Feb. 28 approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) becomes the second chimeric antigen receptor T-cell (CAR-T) therapy to treat multiple myeloma. Payers report being less likely to prefer it over some or all other multiple myeloma treatments with a similar indication, but oncologists are showing more enthusiasm for prescribing the new agent, according to Zitter Insights.

The FDA approved Carvykti for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The product is a B-cell maturation antigen (BCMA)-directed CAR-T agent. The one-time treatment will have a phased launch and will be available through a limited network of certified treatment centers. The FDA gave the drug breakthrough therapy and orphan drug designations. The therapy’s wholesale acquisition cost is $465,000.

Pharma/PBM Contracts Are Increasingly Complex, Opaque

Gaining market access for therapies is key to pharma manufacturers’ success. And it’s not merely access but where on a formulary that access occurs — as well as the formulary tier of competitor products — that’s crucial. To help secure placement, drugmakers enter into contracts with PBMs — and, increasingly, their group purchasing organizations (GPOs) — entities that in turn enter into pharma contracts on behalf of their health plan and employer clients. But these contracts have grown increasingly complex and opaque, and companies should ensure they understand exactly what they’re signing, say industry experts.

These contracts are proprietary, almost always have nondisclosure clauses and vary by manufacturer, PBM and GPO, so many details around them remain unknown. However, sources tell AIS Health that certain standard items should be included. Those include “definitions, financial terms, requirements to qualify for payments, payment timelines, data sharing, confidentiality,” among other aspects, says Katie Asch, Pharm.D., senior director and U.S. consulting pharmacy practice lead at Willis Towers Watson. In addition, states Jenisha Malhotra, senior manager in Risk & Financial Advisory at Deloitte Life Sciences & Health Care, other items that may be addressed are details around the effective dates of the contract; pricing or incentives, including rebates or discounts; eligible products; responsibilities of the contract signees; and eligibility requirements, including eligible facilities.

Similar Adherence Is Seen in Digital, Telephonic Offerings

To serve patients wanting the ability to refill specialty prescriptions online rather than telephoning a pharmacy, AllianceRx Walgreens Prime launched its digital service offering in late 2019. A recent study of people with multiple sclerosis (MS) revealed similar rates of adherence — measured by proportion of days covered — between people managing their prescriptions via online tools vs. telephonic engagement.

In addition to offering self-serve refill requests, the company “wanted to ensure patients using the digital clinical assessment received the same level of quality clinical care required for a specialty patient compared with patients supported by the traditional telephonic process,” says Sabeen Hasni, R.Ph., director of pharmacy quality at AllianceRx Walgreens Prime and a lead researcher of the study. After patients log in and select specialty drugs to refill, they answer operational and clinical questions specific to their condition, including their response to therapy, on-hand supply of medication and side effects. Algorithms can identify those patients who need additional support from pharmacists, and patients can request to speak with a pharmacist at any time. In addition, providers are notified when their patients trigger an intervention protocol, and pharmacists can contact them to discuss next steps in care.