John Meehan, PharmD, MSPBA Candidate

In contracting with drug manufacturers, specialty pharmacies have a variety of decisions to make regarding their offerings and clinical programs. Typically, manufacturers first provide a request for proposal to each interested specialty pharmacy who may be equipped to handle their business.

A section of the proposal should include the data and information services that a specialty pharmacy would agree to provide to the drug manufacturer. A separate section would explain the clinical services that the pharmacy would provide to the patient. These services can be considered either core or enhanced Services.

In considering data and information services that a pharmacy would provide to its drug manufacturer, a pharmacy can determine whether it will offer core or enhanced services. Basic core services would include NDC numbers, prescriber NPI numbers, and de-identified patient demographic information.

In general, most manufacturers will receive these core services, and pharmacies are typically expected to provide them. These core services benefit manufacturers, because they allow the company to predict sales, manage inventory, and target prescribers whose patients would benefit from the product.

Beyond these core services, a pharmacy can propose to offer enhanced services. Enhanced services could include extra, pertinent clinical information, such as lab values. This benefits manufacturers because it provides enhanced support of their post-marketing, phase 4 data reporting required by the FDA.

For example, if a drug is metabolized through the liver, it would benefit the drug company to have results from a liver function test, both prior to and following the therapy. Having hard data would certainly assist the manufacturer in fine-tuning the parameters for initiating and remaining on therapy.

Pharmacies benefit from offering enhanced services because they profit from the extra fees associated with the sale of information. Also, offering enhanced services helps to differentiate from competitors.

Some specialty pharmacies either cannot or will not offer enhanced services, in some cases. In that event, a competitor pharmacy who does offer the enhanced service may have the upper hand.

In considering clinical services, a specialty pharmacy can also determine whether to offer core or enhanced services to patients. Basic core services would include patient communication, medication usage monitoring, financial assistance and benefits investigation.

These core services allow patients to adhere to their prescribed therapy and realize the benefits of the medication. Most patients have come to expect this level of services, as they often rely upon health care providers to openly communicate medical advice, answer questions, or respond to concerns while in the office.

Beyond the core services, specialty pharmacies could also offer their patients more enhanced services. Enhanced services may include communication via text messaging or online video chatting services, such as Skype.

Further, enhanced services for clinical patients could include closer monitoring of drug inventory in the patient home through use of advanced technologies. Patients would benefit from this type of services because they would be provided with a more personalized approach to their drug therapy management.

Often, patients with a more customized or user-friendly experience show better adherence to their treatment, and therefore more positive outcomes. This benefits the patient, health care provider, and the drug manufacturer in important ways.

However, there are down sides to offering enhanced services. Enhanced services cost more for the specialty pharmacies to provide, as they require adjustments to the workflow and deviations from the standard operating procedures.

For example, a specialty pharmacy that offers online live video consultations would incur costs to pay for the software, to train their staff in using the software, and may have to incur costs to ensure that the patients have access to software. While the benefit could be great overall, the up-front costs and costs of maintaining the services could deter some specialty pharmacies for offering that amenity.

In choosing to offer core or enhanced services, pharmacies must be professional and clear in the way that they categorize their offerings. One pharmacy’s core service could be considered an enhanced service if no other pharmacy offers it.

In that case, a third-party consultant would provide a fair-market evaluation of the service to determine whether or not it could be considered core or enhanced. In another case, a pharmacy who attempts offer a service to everyone, but bills a higher amount to only some clients for identical services, could be liable for losing future contracts.

Clearly, specialty pharmacies must be cautious and precise in determining what offerings fall under core or enhanced services for both their manufacturers and patients. Moreover, as the industry progresses, specialty pharmacies must continue to advance their offerings, as the standard for what was once considered an enhanced becomes a core service.

The bar will continually rise and specialty pharmacies must innovate and drive progress forward.

John Meehan earned his PharmD degree from Duquesne University in 2010. John worked in retail pharmacy in rural North Carolina before transitioning to a clinical pharmacist position at Chartwell PA in Pittsburgh, PA. John is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines.

Articles

Specialty pharmacies have multiple decisions to make for clinical programs that accompany a contract with a manufacturer.

What Differentiates Effective Core Services from Enhanced Services in Specialty Pharmacy?

In a relatively brief period of time, specialty pharmacy has gone from its unnamed, semi-nebulous infancy to a solidified section of pharmacy that now drives the practice as a whole. Specialty pharmacists apply a hands-on approach to patient-centered care that has helped maintain the profession’s reputation for trustworthiness and excellence.

Pharmacists genuinely care for their patients, and in an ideal world, the profession would work so well providing therapy that they would find themselves out of a job. The profession of pharmacy will be needed and active until all diseases are cured, and specialty pharmacy is the channel to push this goal forward.

While none of us may be around to see that day, and it is hard to imagine a disease-free future, this lofty goal is nonetheless one to strive for.  Pharmacy has had a wonderful history, and will undoubtedly see a bright future. The tools used with precision to apply the art of pharmacy have served the profession well in the past, and those same knowledge-based tools will benefit pharmacists and their patients in the future.

Specialty pharmacy relies heavily on the constantly-evolving development of new medicines and drug therapies. The research and development of drugs has extended life expectancy, allowing for many diseases and infections to be thought of as nuisances, rather than death sentences as they had in the past.

As an example, because of the variety of antiretroviral medications available to treat HIV patients, those diagnosed with HIV can receive treatment to “live longer, healthier lives,” the National Institutes of Health states. A more specific example of drug therapy developed to save lives that were once deemed incurable involves the novel therapy Kalydeco (ivacaftor).

This drug is used to treat patients with cystic fibrosis caused by the G551D mutation in the cystic fibrosis transmembrane regulator gene. FDA Commissioner Margaret A. Hamburg, MD, describes Kalydeco as “an excellent example of the promise of personalized medicine — targeted drugs that treat patients with a specific genetic makeup.”

Specialty pharmacy promises to be at the forefront of this type of drug therapy treatments. Specialty pharmacy is a channel through which personalized medicine can evolve and guide patients to success. A unique feature of specialty pharmacy is the patient population that it serves.

The field treats patients who suffer from degenerative disorders, diseases that appear from recessive traits and other rare ailments. At times, the patient population can be large, such as among those presenting with hypercholesterolemia. In other cases, the patient population is extremely small, as with the patient population presenting hemophilia.

In all cases, the specialty pharmacist must be equipped to be the drug therapy expert and clearly understand the side effects, dosing, and administration techniques to treat their patient. A benefit that specialty pharmacy provides is that pharmacists can dedicate more time to focus specifically on their patients and ensure that the patient receives closely examined care.

This is due in part to the way that specialty pharmacy is designed to facilitate health care for people who cannot afford to fall through the cracks. For new pharmacists entering the profession, specialty pharmacy is a great avenue to build a career.

Specialty pharmacy allows professionals with a variety of interests to participate, whether they want to focus on patient care, drug research, financials, or have a desire to learn about the cutting edge of medicine. The role of a specialty pharmacist often involves working in conjunction with other health care professionals, including nurses, doctors, and other clinical staff.

Through professional collaboration with other health care providers, a new pharmacist in the field can learn a great amount about treating their patients and working to build an overarching treatment plan. Additionally, young pharmacists seeking to develop a professional trajectory can rest assured that entering the specialty pharmacy field would promise them a long career path.

Specialty pharmacy will clearly be needed and welcomed by the medical community for the long-term foreseeable future. With advances in personalized medicine and an ever-growing focus on research and development, specialty pharmacists will always have more chances to get involved and opportunities to grow.

Clearly, specialty pharmacy is an exciting endeavor for pharmacists and patients. The practice of medicine is better off because of the competent minds that comprise the specialty pharmacy field. In the future, specialty pharmacy is poised to grow even more valuable and necessary, as it stands at the forefront of patient care and drug treatments.

earned his PharmD degree from Duquesne University in 2010. John worked in retail pharmacy in rural North Carolina before transitioning to a clinical pharmacist position at Chartwell PA in Pittsburgh, PA. John is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. 

Specialty pharmacy relies heavily on the constantly-evolving development of new medicines and therapies.

Specialty Pharmacy: Thoughts on a Blossoming Industry

Outcomes are the ultimate measuring stick for specialty pharmacies, because they are intimately tied to patient care. Specialty pharmacy serves a patient population that would otherwise be lost without the service and care provided by these pharmacies.

Frequently, the “high touch” focus that specialty pharmacies are able to place on their patients cannot be replicated by other pharmacies, or even some medical offices. This focus allows patients to achieve results that are expected by their drug therapy.

Patients achieve results when complex therapy is expertly guided by a specialty pharmacy with regards to storage, administration, and side effect management. Patients will also be compelled to work towards positive outcomes when they see the improvements on their quality-of-life.

For example, those suffering from rheumatoid arthritis are driven to remain compliant because their health and ability to lead a normal life is directly related to their ability to walk and use their hands. Patients with rheumatoid arthritis care about their health outcome.

Doctors care about their patient’s health, and are invested in the health outcomes of their patients. If a doctor cannot see the benefits of drug therapy, then they may be less apt to prescribe the drug.

If the physician does not see the benefit of the patient receiving care from a specialty pharmacy, then the specialty pharmacy is not doing a proper job. Specialty pharmacy can provide benefit to medical providers by communicating when milestones, or even basic progress, is achieved to the doctor or medical staff.

A doctor’s reputation is impacted by the level of health and wellness their patients receive. A patient who experiences significant benefits or improvements in health can be a great advertisement for the prowess of a physician.

Clearly, physicians are aligned to appreciate the benefit of positive health outcomes that their patients experience.  When patient care can be proven effective, benefits are realized among patients, doctors, pharmacies, payers, and drug manufacturers. 

For pharmacies, measuring outcomes is a critical step in demonstrating their ability to provide patient care that creates positive clinical outcomes, and adds value by proving the pharmacy’s competency in managing disease states.

Pharmacies that track and drive outcomes will be perceived as more valuable partners to payers, who will trust the pharmacy’s professional expertise in managing their patients. Additionally, these pharmacies will benefit from maintaining lines of business with their partners, and adhering to their contractual obligations to provide appropriate, effective, and thorough care.

As a result of proving their value with positive patient outcomes, pharmacies will be better positioned to maintain current professional partnerships, while expanding and growing their business. In order for patients, doctors, or pharmacies to benefit from outcome management, the proper steps must be taken to ensure that pharmacies are tracking the metrics that produce the best picture of health benefits.

The most critical item to consider and evaluate is clinical response. Clinical response can involve activities of daily living, including the ability to walk up or down stairs, the dexterity to tie your shoes, or the capability to consume a meal with family.

For a pharmacy to properly measure a clinical response, it is important to first obtain a baseline, or a measurement of typical patient performance for a given action or test. Once a baseline is established, a pharmacy can then measure the variation of patient results that may fall below, or rise above their original baseline values.

Additionally, a pharmacy seeking to evaluate clinical response should also consider patient-reported quality-of-life. If a patient can communicate improvements or declines in their daily lives while following drug therapy, the pharmacy can glean better insight on the therapeutic benefit.

This element of clinical response is more difficult to quantify, as it is inherently qualitative, but can nevertheless provide more insight for pharmacists. The use of smart tech in this instance, such as wearable pedometers, smart watches, etc, can provide backing evidence for patient-reported claims.

A separate metric that correlates to outcomes and should be considered closely, is patient adherence to drug therapy. Adherence relates to outcomes because a patient must take the drugs in order to benefit as expected.

An old measurement system of adherence was medication possession ratio (MPR). MPR could result in values greater than 100%, and was not a true measure of whether the patient had the drug when they needed it.

For example, refilling a drug three weeks late could be hidden by three subsequent refills a week early. The better recognized metric has become percentage of days covered, or PDC.

PDC helps to remove ambiguity by simply considering whether a patient had the drug when they were supposed to. The reason adherence is monitored is because it gives support to clinical outcomes.

If the patient reports they are not achieving any benefit, but they also have not refilled the prescription in a few months, then clearly those issues are related. Similarly, if a pharmacy can prove outcomes and show a high rate of PDC, then it is reasonable to find a relation in the metrics. Granted, high PDC does not guarantee positive health outcomes, but it certainly makes them possible.

Ultimately, the value of outcomes will be determined by how applicable they are to real life, how measurable they are, and how quantifiable they are, so that they may be aggregated and examined to produce useable results. Pharmacies must therefore continue to track and measure outcomes, while making an effort to recognize the individual patient’s response to their specialized care plan.

John Meehan earned his PharmD degree from Duquesne University in 2010. John worked in retail pharmacy in rural North Carolina before transitioning to a clinical pharmacist position at Chartwell PA in Pittsburgh, PA. John is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines.  

Patients achieve results when complex therapy is expertly guided by a specialty pharmacy.

How Specialty Pharmacies Influence Patient Outcomes

Data collection and mining is essential to the progress of specialty pharmacy.

Clearly, pharma will keep pushing forward with data requests and reporting mandates, and therefore pharmacies that can keep up will win more business. Also, it wouldn’t be surprising if accrediting bodies began to focus on data reporting capabilities as well, to further raise the bar for the industry.

Claims level data is a must for all pharmacies, but it only scratches the surface of what specialty pharmacy is able to provide. Outcomes-based payment models are here to stay, and the ability for a specialty pharmacy to provide a deeper look and stronger support of outcomes will benefit patients, payers, prescribers, and manufacturers.

The basic claims level data, including NDC number and prescriber NPI number, will not be enough to compete in the future with greater data requirements. It is necessary to ensure that current data are reproducible and easy to categorize, store, and sort.

The ability to add data points to each step of the process in filling a script is already valuable. Key stakeholders, including payers and manufacturers, want to know what a specialty pharmacy’s time-to-fill is. When the specialty pharmacy can break down the steps, the pharmacy is able to give a clearer picture of the value provided by servicing patients.

In addition to prescription fill data, clinical and outcomes data will become more and more valuable. Manufacturers want to be able to publish evidence of their drug’s worth in ongoing trials, and a specialty pharmacy’s ability to deliver key clinical data will streamline the process for manufacturers, and make the specialty pharmacy an asset moving forward.

If a pharmacy can capture fibrosis scores, genotypes, and quantified patient reported measures, and then attach that to a script fill, the pharmacy will not only be providing greater evidence of worth to health plans and manufacturers, but also will be able to capitalize financially as a result. The ability to effectively manage patients, coupled with the ability to provide sortable evidence supporting patient care, will allow specialty pharmacies to command a higher dollar value for their data.

The financial reward for stocking medication, and efficiently dispensing it, may be less than the reward for returning information tied to caring for the patient in between refills. It is reasonable to expect that dispensing patterns could be predicted based upon trends in reported side effects, lab values from bloodwork, or even prescriber evaluation of the patient.

If a drug company knows there is a point where a block of prescribers switches from one product to another based upon prescriber notes, they will be able to better allocate resources to supply chain and marketing efforts. A specialty pharmacy can provide access to this data if they have a strong relationship with prescribers, electronic health records, and labs.

The trick will be to effectively quantify data in a manner that can be sorted and interpreted. For example, creatinine values may not need to be explicitly known, but a range or trend would be useful for reporting purposes.

If a pharmacy has access to electronic health records, and can preemptively perform a benefit exploration based upon prescriber documentation, then time-to-fill could be shortened. It is clear that superior data will allow a specialty pharmacy to rise above peers in the eyes of manufacturers, but it will also help lead to better outcomes for the industry as a whole.

If specialty pharmacy can proactively set the bar higher on reporting back to monitoring agencies, then the industry will be put in a position to help shape the future, as opposed to be at the mercy of regulation. Specialty pharmacy could potentially report classification of an organism, and confirm susceptibility prior to dispensing future classes of antibiotics, which could slow the spread of mutating drug-resistant virus and bacteria.

Specialty pharmacy will be in a position to confirm genotypes and monitor outcomes when these drugs are dispensed. There is every reason to believe that the benefits of drug therapy in the post-marketing setting will become realized, which likely were not tested in trials ahead of time.

By more quickly identifying patient health trends after drug approval, outcomes benefits may be multiplied, as prescribers will have a clearer picture of how to treat patients. Because specialty pharmacy is at the intersection of patient and industry, the profession is in the unique position to shape the future of health care.

By providing more drilled down data, analysis previously unrealized will grow and benefit all stakeholders.

Adding and analyzing data points at each step of the treatment process in specialty pharmacy can enhance patient care.