Market access

Demy-Colton Panel Explains Importance of US Market Access Planning Prior to Phase III Trials

Hogan Lovells has partnered with Demy-Colton to host a special three-part webinar series focused on US market access for life sciences companies, providing companies that are new to the US market or looking to get started in the United States, especially early-stage biotechnology companies, with the basics of governmental and commercial payer rules. The first in the series featured Hogan Lovells partners Alice Valder Curran and Beth Roberts, as well as Kave Niksefat, Managing Director, Inflammation Business Unit, at Amgen. Together, they discussed key issues that new drug sponsors need to consider early on when planning their clinical and market access strategies.

In the article below, we summarize the main takeaways from this first webinar. You can access the first two parts of the series and register online for part three here:

May 4:Making It Real: What does an early stage market access strategy look like?

May 18:Sustainability: how to prepare a value-based market access strategy

Kick off this year Demy Colton U.S. Healthcare Market Access Webinar Series, Alice Valder Curranpartner at health practice Hogan Lovells, urged sponsors of new drugs to say that “a little work on the front end can make a huge difference in creating greater flexibility for your go-to-market strategy and access of patients once you finally get that FDA approval and are ready to go to market. This theme was echoed throughout the discussion, and Kave Niksefat, general manager of Amgen’s Inflammation business unit , highlighted how “access has become the single most important success factor in the United States. [drug] market,” which means conversations around market access should start in phase I clinical trials, especially for biotech companies.

The panelists focused their discussion on four fundamental questions for sponsors of new medicines:

  1. Indications: What are the indications for which my molecule is being studied and in what order do you currently plan to pursue the study and approval?

  2. Mix of payers: For each of these indications, who will pay for the drug (for exampleMedicare, Medicaid, or commercial payer)?

  3. Dosage: What is my dosage and in which product presentations? (for examplebased on weight vs. fixed uprights)

  4. Pricing: What is my pricing strategy, and should I review [based on that strategy] the order in which I plan to pursue review and approval?

Summarizing Payers in the U.S. Healthcare Market, beth robert, partner at health practice Hogan Lovells, highlighted how Medicare Part B sets the standard of coverage that other payers in the U.S. market plan to follow. Notably, Roberts explained that whether a drug is paid for by Medicare Part B often depends on whether a drug is administered by a physician and considered “reasonable and necessary” by CMS; and that if Part B coverage is not available, drug sponsors will want to apply for Part D coverage. The Medicare Part B and Part D systems “work together,” Roberts explained. Roberts noted that sponsors need to think about how to overlap two approaches: whether a drug will generally be self-administered or will be covered by Medicare Part B, for as long as possible, and be mindful of clinical trial design and drug label content accordingly. Roberts also explained how new drugs used in a hospital setting may be eligible for New Technology Supplementary Payments (NTAP) and the relevant cost thresholds that must be met to be eligible for this coverage. Roberts noted, however, that there are exceptions to every rule that could affect coverage and reimbursement results. Responding to questions in the Q&A portion of the webinar, Roberts clarified some of the requirements for NTAP qualification.

Roberts stressed the importance of knowing whether payment for a drug can be “bundled” or integrated with payment with another therapy, which could potentially reduce the amount a drugmaker can charge for its product. This has several key implications for drug sponsors; for example, an unpackaged indication would often have to be released first to ensure separate payment for a longer period, Roberts advised.

Explaining how to calculate the average selling price (ASP), Valder Curran warned sponsors that if Part B payment rates are expected for a drug, they will have less flexibility in pricing their drug if different indications and different versions of the same product are approved under the same drug application. Roberts echoed the importance for a drug sponsor to map each drug indication under investigation, and when they plan to bring that version of the drug to market. Valder Curran said that while sponsors should begin product planning with their FDA strategy, there will be a feedback loop involving revisiting FDA concerns and coverage as drug sponsors reconsider their payer strategy. Valder Curran stressed that it is important that sponsors make “considered decisions about what [they] continue, when and how. Roberts also pointed out that labels can be modified appropriately to provide an advantageous reimbursement strategy.

Turning to the analysis of non-Medicare payers, Valder Curran described Medicaid as the “payer of last resort” because it is often secondary to paying Medicare, while noting the importance of stakeholders entering into the reimbursement program for Medicaid drugs (MDRP). Summarizing how federal programs require disclosure of drug prices, Valder Curran warned that drug sponsors may not be able to escape the first price they set for the first version of their product because it could end up impacting their Medicaid reimbursement for the drug throughout its lifetime. However, Valder Curran pointed out how there will be separate pricing data and a separate rebate amount for each dosage form and each strength for each drug (the so-called ‘NCD-9’) – underlining how that is what provides sponsors with flexibility in pricing their drug product in the future.

Discussing concerns about seeking payment from commercial payers and Medicare Part D, Niksefat cautioned that the private healthcare market is changing rapidly and constantly changing. He explained how the authority to decide whether or not to pay for drugs within Pharmacy Benefit Managers (PBMs) typically rests with three different groups that have distinct roles and responsibilities: the clinical team and the patient relations team. Industry, Pharmacy and Therapeutics Committee and Business/Economic Benefits Committee. These teams focus on finding the lowest net cost of drug products; However, Niksefat explained, PBMs are also working to ensure that they can meet their commitments to drug-related customers, such as their rebate guarantees, which pharmaceutical companies must take into account when setting the price. price of their product. In all of these considerations, Niksefat highlighted how the future landscape of commercial healthcare payment remains unpredictable and therefore, he concluded, “agility is the key to success for drug sponsors.” .

In the Q&A segment of the webinar, when asked if it is inevitable that the price paid for drugs will erode over time, Niksefat said that net industry prices are expected to continue to decline in the future. . Asked if Quota Neutralizers are included in the ASP calculation, Valder Curran explained how a new rule requires any Accumulator Adjustment Program money captured by PBMs to be counted in the “ best price ” ; however, CMS has not issued any guidance on this as far as ASP is concerned.

Asked about reimbursement for products associated with companion diagnostics, Roberts advised sponsors to ensure the companion diagnostic is included in the labeling to ensure coverage. Asked about the different decision-making roles within PBMs, Niksefat replied that payer decision-making often rests with business/economic impact committees.

The full webinar summarized above is available for viewing online here. The second session,Making It Real: What does an early stage market access strategy look like?took place on May 4 and ran through real-life hypotheses that incorporate key learnings from the first webinar. The second webinar is available online here. On May 18, panelists will discuss “Sustainability: how to prepare a value-based market access strategyand strategies to prepare for possible changes to existing regulations.