David M. Franklin, MSA

The specialty drug market certainlyhas everyone’s attention.Depending upon which study youwant to believe, the specialty drug marketis the fastest growing area of healthcare in terms of cost, experiencingbetween 20% and 40% growth per year.Providers, payers, and drug manufacturershave all taken note, and arescrambling to manage this emergingenvironment. The rate of introductionof new therapies is stunning, and keepingup with the changes represents asignificant strategic challenge to all parties.The individuals who manage thisdevelopmental phase most skillfullywill ultimately benefit the most.

It is difficult to discuss somethingwithout first defining it, and clarifyingexactly what a specialty drug is canbe particularly challenging, as there isno standardized definition. In general,

 Many such drugs cost hundreds or thousands of dollars per treatment.

 Many are used to treat diseases where therapy is provided over a longer period of time.

 The clinical acuity of related treatments is often high, requiring the provision of an abundance of professional services.

 Refrigeration, special storage requirements, and the ability to be mailed are often cited as defining elements.

 Drugs based on protein molecules derived from living cells or other such biologically based medication therapies are often classified as specialty drugs.

 Specialty drugs are often injected or infused, and also may be administered transdermally or via inhalation.

Benefit plan and reimbursementinfrastructure vary significantly, alternatingbetween standard pharmacy andmajor medical benefits. Whereas pharmacyhas historically been viewed asa product-based modality, the servicecomponent of specialty drug administrationis often significant.

A pharmacy’s patients can be quitediverse as well, each with divergentexpectations. For instance, hospitalsneed a safe and effective site of serviceto discharge inpatients; drug manufacturerswant high-quality providers thatcan supply outcomes information; andpatients want to receive the highestquality of care. Also, pharmacies desireassurance of reimbursement and a fairreturn on investment.

A pharmacy seeking to enter thesepotentially profitable markets must beable to serve all the needs of thesedisparate constituents. Key elements todeliver include:

In theory, this is accomplished via contractingwith the drug manufacturers, butin practice these agreements are difficultto acquire, as the manufacturers haverestricted distribution channels, detaileddata submission prerequisites, andextensive clinical program requirements.At minimum, expect to be required toprovide complete patient demographics;detailed clinical outcomes information;patient and physician satisfaction surveyresults; and data submitted on a timelybasis and in a format that meets allmanufacturer requirements.

Successful providers in the specialtydrug arena must be able to offer not onlyproducts and data, but also comprehensiveclinical services including pharmacokineticdosing, which requires accessto lab and other diagnostic test results;sterile compounding, including meetingthe requirements of USP 797; nursingservices where applicable; and comprehensivepatient education, whichis considered a core component ofany effective disease state managementprogram.

This means not just paid, but paid fairlyand with respect and consideration ofall of the components that go into providingsuch a comprehensive and clinicallyacute service. Health plans that areaccustomed to the more traditional roleof pharmaceutical intervention often donot realize the cost and level of servicenecessary for an effective specialty drugprogram. This has led to attempts tocommoditize the field into nothing morethan a derivative of cost of goods sold.Providing education to those responsiblefor reimbursing health-related servicesis a key component of a specialtydrug program.

If you can master this environmentby developing comprehensive patientcare programs, gaining access toapplicable medications, and acquiringpayer source contracts, you may beable to play a role in the specialty drugmarket.

Articles

Pharmacies entering the specialty drug market will need to deliver key elements in order to succeed.