Pedram Pahlavan, PharmD, BSP

Specialty pharmacy is growing rapidly and becoming a significant consideration for health systems and manufacturers across the United States. This is due to changing trends in drug manufacturing and the increasing importance of adherence and data reporting as more health systems are investigating integrated ambulatory specialty pharmacies.

For the last 10 years, manufacturers have become more focused on creating specialty medications for chronic and complex disease states. Often, the populations for these disease states are small, and industry and regulatory trends have been driving this shift.

The number and cost of specialty pharmaceuticals continue to draw the attention of the health care community as providers, payers, and patients work to assess and manage the expense of these medications. This trend is not expected to change, especially given the metrics related to this practice category.

the FDA approved 21 additional new molecular entities

. Of those products, 12 (57%) are considered specialty pharmaceuticals based upon 

such factors as the indication and intended population of use, administrative and monitoring considerations, cost, and/or limited distribution processes

US expenditures for specialty drugs have doubled from $83 billion in 2013 to $157 billion in 2017

. Including the expense for orphan drugs (ie, "ultra-specialty" medications), total spending on specialty drugs reached $200 billion in 2017. Combined, the categories of specialty pharmaceuticals and orphan drugs are close to equaling the amount spent on traditional medications in the United States.

Source: Orphan Drugs in the United States, Growth Trends in Rare Disease Treatments, October 2018. IQVIA Institute.

https://www.iqvia.com/institute/reports/orphan-drugs-in-the-united-states-growth-trends-in-rare-disease-treatments

Specialty pharmacy is projected to grow to $500 billion by 2020.

 to increase to 50% of drug costs by 2020

		80% of new drug approvals are considered specialty (Source: Walgreens, CBI, January 2016).

		Specialty drugs currently represent just under 

2% of the prescriptions, but nearly 40% of spending in the same channels

Drug manufacturers aren’t producing specialty medications without a good reason. Demand has been steadily rising for specialty medications that treats specific disease states. Drug manufacturers are also being asked to create more specialty drugs that treat smaller sections of the population.

Treatments for many common and acute disease states have been the primary focus of manufacturers for a long time, creating an increased demand for medications to treat chronic disease states with small populations. Historically, because specialty medications impact such small markets, it was hard to even reach a proper sample size in testing for FDA regulations.

Specialty drugs are often incentivized through the 

 of 1984, helping to increase profitability through tax benefits and market exclusivity agreements. This has allowed manufacturers to dedicate more resources to research and development for diseases that impact a much smaller portion of the population.

These regulations also allow manufacturers to test with fewer patients in human trials. Since these diseases are chronic, rare, or complex, the drugs require more education and care, creating the current adherence problem facing pharmaceuticals.

The benefit of working on specialty drugs that are more personalized and precise is that they allow the medication to reach an effective state faster and reduce adverse effects and reactions. These outcomes also benefit health systems through the reduction in risk associated with a given medication.

The growth of specialty pharmacy is directly related to the growth of specialty and limited distribution medications. More health systems will begin to adopt integrated specialty pharmacies to better manage their patient care and increase adherence rates.

More health systems are integrating specialty pharmacies to facilitate collaboration between a holistic care team consisting of pharmacists and physicians. A health system specialty pharmacy provides greater control over the clinical outcomes for patients due to continuous care provided by pharmacists and physicians working side by side.

Tracking the Future of Specialty Pharmacy 2018 Report by CSI Health Group

, 58% of health system specialty pharmacies cited continuity, comprehensiveness and coordination of care, and speed to therapy as the main benefits.

The increased exposure and coordination lead to better management of adverse effects and adherence. Patients who exclusively use specialty pharmacies had a 

60% higher likelihood of achieving optimum adherence

Health system specialty pharmacies are driving better care for patients, leading to better outcomes, and meeting the needs of the market shift to a value-based reimbursement model.

In summary, specialty pharmacy is going to continue to grow at rapid rates due to several factors:

		An increased focus on the creation of specialty and limited distribution drugs.

		An increase in health system-based specialty pharmacies that are better equipped to provide continuous care between physician and pharmacist.

		The continued rise in personalized medications for complex and rare disease states.

Practitioners and health systems will need to adapt so they can provide a better care experience for their patients, while also meeting the requirements for their value-based reimbursements.

As specialty pharmacies continue to grow, health systems will need to evaluate whether an integrated specialty pharmacy is right for them. Those that take steps to implement a specialty pharmacy will see higher adherence rates, an easier to manage reimbursement system, and possibly a reduction in risks.

As a Senior Director of Specialty Pharmacy, Pedram Pahlavan develops, implements, and maintains a health system-centric specialty pharmacy solutions.

Articles

As specialty pharmacies continue to grow, health systems will need to evaluate whether an integrated specialty pharmacy is right for them. 

Specialty Pharmacy By the Numbers

This article was originally published by 

Specialty pharmacy remains a growth and patient care opportunity for large health systems (ie, academic medical centers, integrated delivery networks, and community-based hospitals). Not only can they improve care and enhance continuity of care to the patients they serve, but also increase revenue streams and satisfaction among patients and physicians while reducing the risk in a value-based reimbursement model.

Operating a specialty pharmacy is a great benefit to a health system that adopts it early, while those who wait are going to face higher risks and have a lower probability of success.

Here are 5 ways health systems can be affected by not opening an integrated specialty pharmacy:

While third-party pharmacies fulfill delivery of specialty medications to patients, they reduce the ability of physicians to easily monitor and track the patient’s health, making it harder to offer the highest possible quality of care. Where this becomes especially important is continuity of care and management of adverse effects or new symptoms.

Without the benefit of real-time transparency that a shared electronic health record (EHR) provides, it becomes more difficult to manage and intervene in patient care complications and prevent a readmission or visit to the emergency department.

Working through a health system specialty pharmacy may not always feel the most comfortable to patients, as many associate hospitals are critical care settings. Although it may feel more familiar to go to an offsite specialty pharmacy, it’s not always easier for patients.

With physicians and pharmacists working together through an on-site pharmacy, they can provide education and management of medication while proactively adjusting treatment based on adverse effects and focus on increasing adherence.

Integrated specialty pharmacies at health systems give physicians and the multidisciplinary care 

team of pharmacists and nurses better access to their patients’ records

. This allows them to better manage and monitor their patients’ compliance and persistence of use for prescribed medication. The ability to impact adherence of patients saves health systems money and results in healthier patients with fewer medication-related complications.

2. Preparing for Value-Based Reimbursement

Health systems and hospitals are now seeing their profitability directly tied to patient outcomes due to the transition from fee-for-service to value-based reimbursement. Transferring the pharmaceutical care of patients to commercial specialty pharmacies gives up control over the total care of a patient, which increases the risk to the health system.

If a patient sent to an outside specialty pharmacy does not adhere to their medication regimen and is readmitted to the health system, then the cost for the interventional care comes without any additional reimbursement to the health system. This also results in reduced quality of care for the patient.

Health systems moving to a fee-for-value model and accountable care organizations (ACOs) are in alignment with payers around financial incentives. Outside specialty pharmacies, organizations incentivized to fill the most prescriptions possible, are not aligned with this system. Specifically, this makes the health system and ACOs responsible for any difference in allocated cost from capitation or reimbursements if the outside specialty pharmacy charges more than allocated for the medication.

Establishing an in-house specialty pharmacy is a win-win for health systems because it provides greater control over managing the patient. Adherence and the impact on readmission are vital to the health systems viability in a value-based care model.

Specialty medication and limited distribution drug growth

 are projected to account for half of all drug sales by the end of 2020, according to the 

National Association of Specialty Pharmacy

. As more specialty drugs are developed and added into a limited distribution channel, it becomes harder for a traditional hospital pharmacy to access the medications their patients need. Integrated specialty pharmacies give patients access to the specialized drugs they need on-site more quickly, often on the same day of their visit with the physician at the specialty clinic.

If health systems don’t start taking the steps required to implement a specialty pharmacy now, they could be boxed out of the opportunity in the future as the competition in the specialty pharmacy space grows.

Although implementing a fully integrated specialty pharmacy requires a meaningful investment, many health systems are starting with a basic model that includes one or two more familiar therapies to gain access to preferred channel drugs, such as hepatitis C medication. This allows for additional revenue immediately that can be invested in a more robust specialty pharmacy over time.

4. Lower Patient and Physician Satisfaction

The lack of an integrated ambulatory specialty pharmacy can result in lower satisfaction across the board, from providers to patients. Without an integrated health system specialty pharmacy, it means that physicians have trouble giving their patients the pinnacle of care they strive for. This also creates an extra burden on their position of treating these specialized disease states that are often chronic and severe.

Not only can physicians become frustrated, but patients feel less satisfied if they feel their care is compromised or can’t get the answers they need from an off-site pharmacy. Additionally, patients face increased adherence complications from a non-integrated pharmacy, and they also don’t get the same amount of collaboration and follow-up with both their physician and pharmacist.

Lower satisfaction from both patients and doctors can make a health system less competitive, and less attractive for future referrals and provider expansion. Although this is not at the forefront of problems in the health care industry, it is something that will have a more significant impact as specialty pharmacy continues to grow and both patients and doctors have more choices between other established ambulatory/specialty pharmacies.

As stated above, specialty drugs will make up 50% of all medicine spend by 2020. These drugs are increasingly becoming part of how health systems are staying profitable.

Not integrating specialty pharmacy increases the financial risk for health systems and allows competitors to take a larger market share. The revenues from specialty medications can be a significant help to hospitals and provide them with additional financial margins to improve the quality of care across the board.

 are becoming an increasingly important factor in determining profitability and competitiveness with health systems and hospitals. Specialty medication continues to expand in the market and will continue to impact the ability to offer quality and continuity of care. If you have not yet considered integrating a health system specialty pharmacy into your organization, now is the time to evaluate and act.

As a senior director of Specialty Pharmacy, Pedram Pahlavan develops, implements, and maintains a health system centric specialty pharmacy solution

Operating a specialty pharmacy is a great benefit to health systems that adopt it early, while those who wait are going to face higher risks and have a lower probability of success.