Susan Cantrell

As we enter 2020, the Academy of Managed Care Pharmacy retains a clear-eyed view of where managed care pharmacy has been and where it’s going. Our vision of ensuring patients can access the medications they need at a cost they can afford will guide our priorities over the next 12 months.

AMCP’s priorities include: activate initiatives to address the rising costs of pharmaceuticals; advocate for smart health insurance reforms; continue the shift from fee-for-service to value-based care; better integrate medical and pharmacy data to manage total costs of care; establish standards for evaluating and covering digital therapeutics; and seek legislation that will allow for the exchange of clinical and economic information on medicines moving through the Food and Drug Administration pipeline.

Our profession of managed care pharmacy is small, relative to other pharmacy practices, but we touch the lives of nearly 300 million Americans. That’s why we take these priorities seriously. Let me explain some of them in detail.

Rising Costs of Pharmaceuticals

Everyone agrees on the need to control the rising costs of medications. It’s been one of the key policy issues animating politicians and the public alike. According to a February 2019 survey by the Henry J. Kaiser Family Foundation, nearly 80% of respondents said the cost of prescription drugs is “unreasonable.” But the same survey also found that among those currently taking prescriptions drugs, nearly 75% said, “affording them is easy.”

This presents a mixed picture in which costs are a concern, but where tools of managed care pharmacy are helping the vast majority of Americans afford their medications.

In this vein, AMCP will continue to promote our three-point platform on addressing rising drug costs: ensuring pharmacy benefits offer value for outcomes; employing enhanced approaches to coverage decisions; and fostering competition to lower costs.

We have several initiatives planned in 2020 to advance our position on controlling costs. This year we will hold an AMCP Partnership Forum that examines ways managed care pharmacy can help patients anticipate and manage drug costs. Forum participants will explore both the intended and unintended consequences to patients of various proposals, including changes to rebates for federal programs; requirements for public disclosure and transparency of drug prices; and reforms to pharmacy benefit managers and health plans.

As with all AMCP Partnership Forums, we will offer a set of recommendations on how stakeholders together can lower costs, improve transparency, and help patients understand and manage drug costs.

One of the major drivers of costs, of course, is the increasing number of high-cost specialty medicines coming to market. While these products make up only about 1% to 2% of all prescriptions written, they account for nearly 50% of the total drug spend. This figure is only expected to grow.

To address the spending challenge, we held an AMCP Partnership Forum in December to develop ideas for new benefit and reimbursement designs that allow patients to access needed specialty medications, while also allowing payers to remain good stewards of health care resources. Along these lines, in 2020, we will hold an AMCP Partnership Forum on preparing for and managing rare diseases. Our questions will include how managed care organizations can provide access to these therapies and manage outcomes in an environment of limited health care resources.

Prior Authorizations, P&T Practices

We also will continue our efforts to bring greater efficiencies and improvements to the practice of prior authorization (PA), a long-standing managed care pharmacy tool to control costs. We started this effort in 2019 with an AMCP Partnership Forum that developed recommendations on ways to ease administrative burdens; increase visibility of the clinical and economic value of PAs; and improve communications between managed care, providers and patients to minimize care delays and improve clarity of coverage requirements.

These efforts fit with our recently published set of nine concepts around the effective use of PAs. The concepts center on: patient safety and appropriate medication use; clinical decision making; evidence-based review criteria; automated decision support; transparency and advanced notice; emergency access; provider collaboration; need for timeliness and avoiding disruptions in therapy; and cost-effectiveness and value.

Another related bedrock of today’s managed care system is the use of pharmacy and therapeutic (P&T) committees to evaluate products for coverage and reimbursement decisions. It has been nearly 20 years since AMCP and other stakeholders adopted the Principles for a Sound Formulary System. But changes and evolution in health care suggest the need for updated recommendations from a broad group of stakeholders.

We will continue efforts started during our AMCP Partnership Forum last March focused on reforming P&T practices to reflect the current and evolving health care system. Several themes came to light, including:

• The wealth of new information and data sources available for evaluating the effectiveness of drugs and devices will require additional competencies in new evaluation techniques and methodologies by P&T committee members.

• Managed care organizations have a huge opportunity to engage and incorporate the patient perspective in coverage ­decisions.

• Managing conflicts of interest and establishing organizational policies on transparency are crucial and should be a priority.

AMCP will continue to refine processes around the P&T committee, PAs, and all other areas where we touch the pharmacy benefit.

Washington Agenda: Drug Rebates, IPI, PIE

Entering a presidential election year, policy debates on lowering drug costs will become more intense than ever. AMCP will continue following proposals from the Democratic presidential candidates, as well as those coming out of the White House, including proposals to eliminate negotiated rebates and peg U.S. prices to an international price index.

We are heartened that the Trump administration pulled its controversial proposal to eliminate negotiated rebates for pharmaceuticals under Medicare Part D and managed Medicaid programs. The proposed rule would have eliminated one of the few levers available to lower prescription drug costs.

Another proposal we oppose is the idea to peg the price of Medicare Part B drugs to an international price index (IPI). AMCP believes that government regulation of prescription drug pricing, regardless of its structure, would have an overall negative impact on consumer cost, quality and access to health care benefits. Regulated prices can inadvertently discourage appropriate drug prescribing, dispensing and utilization and reduce innovation.

AMCP will continue to press for bipartisan legislation codifying current regulatory safe harbors that allow for pharmaceutical information exchange (PIE) between manufacturers and population health decision makers.

Eye on States: Medicaid Common Formularies and Prior Authorizations

On the state level, we will continue to advocate for smart changes to the Medicaid managed care programs and oppose those that we feel hinder patient care and choice.

Specifically, we are concerned that a number of state Medicaid programs now preclude managed care organizations from collecting PBM rebates for Medicaid lives. In addition, some states now require Medicaid managed care organizations to maintain common formularies, and even more require a uniform clinical prior authorization form and clinical protocols.

Such controls make it difficult for Medicaid managed care organizations to be creative or competitive with the prescription benefit.

Boosting Uptake of Biosimilars

In other areas, AMCP will continue its advocacy for greater uptake of biosimilars. Last year, AMCP and PRIME Education conducted a survey on barriers to adoption that included concerns about safety and efficacy among prescribers and state laws on substitution and interchangeability. In 2020, we will address barriers that were rated as either “extremely difficult” or “difficult” to overcome, including:

• Concerns about biosimilar safety and efficacy among prescribers: 61%.

• Pricing and contracting issues: 57%.

• State laws and regulations for substitution and interchangeability: 53%.

• Concerns about biosimilar safety and efficacy among patients: 49%.

• Formulary management issues: 35%.

• Concerns about biosimilar safety and efficacy among payers: 23%.

And we will focus on strategies seen as “extremely likely” or “likely” to have a positive impact on overcoming barriers:

• Prescriber education on switching studies: 91%.

• Clear FDA guidance on substitution: 90%.

• Formulary policies for treatment-naïve patients: 87%.

• Prescriber education on real-world studies: 86%.

• Expanded Medicare and Medicaid policies: 84%.

•Reduced cost-sharing for patients: 80%.

Digital Therapeutics: Laying the Groundwork for Coverage Decisions

Another exciting focus area in 2020 is on a new category of therapies known as “digital therapeutics.” AMCP’s Partnership Forum in September 2019 started laying the groundwork for making coverage decisions, including by developing a description of digital therapeutics and how they contrast from other digital health products on the market, such as consumer wellness apps.

A digital therapeutic, the forum participants agreed, is a “high-quality digital intervention, making a medical claim, that is driven by software programs to prevent, manage or treat a medical disorder or disease.” Coverage decisions, meanwhile, will include an examination of safety, efficacy and usability, with formulary considerations based on the product’s medical claim or function.

We will take these concepts to the next level in 2020, particularly as more of these products are expected to hit the market.

AMCP Foundation: Health Care Disruptors and Opportunities

In the coming year, the AMCP Foundation will continue to focus on challenges and opportunities across the U.S. health care system, including affordability and value, optimal coverage, population health management, and the arrival of innovative and curative biopharmaceutical products. The Foundation’s influential “Trends in Health Care: Disruptors and Opportunities” series will be updated in 2020.

As you can see, we have a full and diverse agenda. But the bottom line is AMCP will continue promote policies and best practices that allow patients to get the medications they need at a cost they can afford.

Susan Cantrell is the CEO at Academy of Manager Care Pharmacy.