March 21, 2018

Dr. Silvia Sacalis: The Specialty Drug Decision – Weighing Outcomes and Cost

By Silvia Sacalis, BS, PharmD, VP of Clinical Services, Healthesystems

Silvia SacalisPharmaceutical research & development has become laser-focused on the development of specialized drugs, producing some significant drug innovations over the last several years. The crop of new hepatitis C (HCV) antivirals that first hit the market in 2015 presented hope for converting a chronic disease into one that is instead curable. The same year brought the approval of the United States’ first biosimilar product, which opened the door to greater access and affordability of biologic medications. And this August, the FDA approved the first gene therapy in the U.S., a treatment for select patients with acute lymphoblastic leukemia (ALL), a form of cancer for which few treatment options exist.

Slow But Steady Growth
Drug innovations such as these provide the opportunity to bridge existing gaps in care and reduce the morbidity and mortality associated with chronic and life-threatening conditions. But what role do they currently serve in the care of workers’ compensation populations?

Many workers’ comp payers have seen their proportion of specialty drug spend among total pharmacy costs rise less than 1% over the last year.1 But individual claims impacted by these medications can become dramatically more expensive when considering these therapies can cost up to 40 times more than traditional medications. Specialty spend across healthcare continues to grow, reaching $181 billion in 2016 and driven largely by the autoimmune, HIV, and oncology sectors.2 Continued growth is expected among workers’ compensation claims, as well.

The Specialty Drug Decision Dilemma
Because specialty conditions represent a small minority of worker’s compensation populations, drug formularies traditionally do not include specialty medications. Formulary management can be a useful tool in controlling drug selection and broader use of specialty drugs where traditional drugs may instead be therapeutically appropriate and cost effective. However, it also can present barriers to access for patients with legitimate medical need.

While drug prices are a prevailing conversation around specialty medications, it’s important to also consider critical care decision points that impact disease and overall cost management. For example:

  • Will the medication produce a better health outcome? If a specialty drug provides significant therapeutic benefit over traditional therapy, it has the potential to reduce or even eliminate long-term medical costs associated with chronic and/or advancing disease.
  • How urgently is treatment needed? For cases where timing is critical, such as prophylactic treatment of workers exposed to HIV infection, there must be protocols in place to ensure timely access.
  • Is the patient likely to remain adherent? While they can offer significant clinical benefit over traditional therapies, many specialty medications rely heavily on patient adherence to produce the intended therapeutic effects. Non-adherence can lead to multiple consequences that include relapse, increased symptoms, increased costs due to absenteeism or hospitalizations, and in cases such as viral infection, resistance to drug therapy.
  • Perhaps one of the most relevant examples of how care and cost must be effectively weighed as it relates to specialty medications is in the treatment of HIV- and HCV-exposed workers.

    A Mission Critical Population
    Depending on the population, HIV therapies can be among the most common specialty medications seen in workers’ comp.1 Needlestick and sharps injuries in the workplace can expose healthcare workers such as nurses or emergency department workers to infectious diseases, the most common being HIV, HCV, and hepatitis B.3 The Centers for Disease Control and Prevention (CDC) estimate that approximately 385,000 sharps injuries occur among hospital workers each year.4

    For workers exposed to HIV and/or HCV, time is of the essence. When a worker comes into contact with HIV-infected bodily fluids, prophylactic treatment should be initiated immediately; typically, both HIV and HCV prophylactic treatment are initiated due to risk for coinfection. While specialty drugs for these conditions come at a high cost, delaying treatment comes at an even greater expense: increased risk for infection, translating into chronic and potentially life-threatening illness that will require ongoing treatment for the duration of the patient’s lifetime.

    Off-Label Infiltrators
    The presence of other specialty drug classes infiltrating workers’ comp, such as viscosupplements, however, may not be as well-defined. For example, there has been a significant uptick in the number of hyaluronic acid injections (Synvisc, Orthovisc, Euflexxa) available on the market, and subsequently within workers’ comp claims. These therapies, which are only indicated for the treatment of osteoarthritis (OA) of the knee, can cost a hefty $600-1400 or more per script.1 But they also may be inappropriately prescribed off-label for other body parts affected by OA, a determination that may be extremely difficult when diagnosis is unclear or inaccessible to the workers’ compensation claims professional. In addition, even if these medications are used according to their approved indication, they are not first-line pharmacologic therapy because there is no consistent clinical evidence to support the use of viscosupplementation. Having a PBM partner with the right clinical expertise, as well as clinical programs to ensure appropriate oversight and management of these patients, can help drive optimized functional improvement and effective overall cost containment.

    For an in-depth look at specialty drug trends currently impacting workers’ comp and considerations for management of these populations, we invite you to read our article “6 Specialty Drug Trends Impacting Workers’ Comp Right Now.

    About Silvia Sacalis
    Silvia Sacalis, BS, PharmD, provides clinical leadership and strategic direction as Vice President of Clinical Services at Healthesystems. Her healthcare experience and clinical expertise span the PBM, retail pharmacy and managed care environments. Leveraging her technology background, clinical skills and management expertise, she helps develop and operationalize strategic clinical initiatives to help workers’ compensation insurance payers maximize the impact of a pharmacy benefit management program. Throughout her career, she has held various leadership roles in which she provided oversight of clinical services teams, the development of clinical programs, and integration of analytics technology coupled with clinical consultative support. Dr. Sacalis is a national thought leader and contributor to various industry presentations, publications and interviews.

    Dr. Sacalis received her Bachelor of Science in Computer Science and Doctorate of Pharmacy degrees from the University of Illinois at Chicago.

    About Healthesystems
    Healthesystems is a specialty provider of innovative medical cost management solutions for the workers’ compensation industry. The company’s comprehensive product portfolio includes a leading pharmacy benefit management (PBM) program, expert clinical review services, and a revolutionary ancillary benefits management (ABM) solution for prospectively managing ancillary medical services such as durable medical equipment (DME), physical medience, home health, transportation and translation services. By leveraging innovation, powerful technology, clinical expertise and enhanced workflow automation tools, Healthesystems provides clients with flexible programs that reduce the total cost of medical care while improving the quality of care for injured workers. To learn more about Healthesystems visit

    1Healthesystems findings.
    2QuintilesIMS Institute. Medicines Use and Spending in the U.S. May 2017.
    3CDC Stop Sticks Campaign. Sharps Injuries: Bloodborne Pathogens.
    4CDC Stop Sticks Campaign. Sharps Injuries: Sharps Injuries.

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