Gary Rice, Lynnae Mahaney, Anthony Schueth

The specialty pharmacy ecosystem is complex.

It consists of multiple transactions and moving parts that rely on antiquated, redundant, and inefficient communication via paper, phone and fax.

There is a lack of consistency and agreement in the industry as to terminology and definitions, which often leads to multiple approaches to administration of specialty pharmacy programs and benefits. The impacts of these inefficiencies are cumulative, which impedes speed to therapy by days, and sometimes weeks.

Improving this reality was the focus of an April 5, 2016 meeting of key leaders in specialty pharmacy held at the headquarters of the National Council for Prescription Drug Programs (NCPDP). An 

 Standards Development Organization, NCPDP creates national standards for the electronic exchange of information related to medications and pharmacy services. Attendees included representatives from specialty pharmacies, electronic health record (EHR) vendors, electronic prescribing infrastructure providers, pharmaceutical manufacturers, health care providers and other industry groups.

Industry leaders looked at drivers for change, the current state of specialty pharmacy, the foundations that have been laid by NCPDP, and additional opportunities to customize and standardize processes. The consensus was that immediate focus should be on measureable, near-term processes that could improve speed to therapy.

A number of factors are converging that will increase the urgency for changes in the specialty pharmacy ecosystem. They include:

. Eight of the 10 top highest revenue drugs in 2016 will be specialty. Specialty pharmacy has grown upwards of 20% per year and should account for 40% of all drug spend by 2040.

 According to a report released in 2015, specialty medications represented about 1% of all US prescriptions, whereas they are estimated to contribute up to 44% of the overall drug spend within the next 3 years.

. Two-thirds of new approvals by the FDA are for specialty drugs, not counting the recent introduction of biosimilars.

In 2012, there were more than 800 biologics in the research pipeline and new specialty drugs are coming to market with increasing frequency.

 Specialty medications are expensive. They easily cost $2000 per patient per month, with those at the high end running as much as $100,000 to $750,000 annually, or more.

The affordability of these drugs is a concern for payers, providers, prescribers, and patients.

More patients will need specialty medications.

 The chronically ill are most likely to need specialty medications, and their number is on the rise. About half of all adults in the United States — 117 million people &mdash; had 1 or more chronic health conditions as of 2012, and a quarter of adults had 2 or more. By 2030, the chronically ill population is expected to reach 171 million.

These patients will likely create a flood of new specialty prescriptions, which will overburden the ecosystem and result in bigger treatment delays unless changes are made.

The current specialty pharmacy ecosystem is very complex and consists primarily of paper, phone, and fax communications among the stakeholders along 8 major elements.

. Specialty prescriptions are often sourced and processed differently than non-specialty prescriptions and may be part of an order set including multiple products.

 This is primarily a paper form that specialty pharmacies use to capture the demographic, insurance, medication, and clinical information needed to get therapies to patients. It can range from 1 to multiple pages of information, depending upon the pharmacy, manufacturer, and condition. 

. This is the process of determining whether the medication will be covered under a patient’s medical or prescription benefit coverage and, if covered, how much a patient’s insurance will cover and the amount the patient must pay. Because this is currently done after the prescription is written, there is often a week’s delay in getting benefits verified, and that too, with only 60% accuracy.

. Drug manufacturers and specialty pharmacies often require the use of “hubs” for specialty medications. “Hubs” provide comprehensive patient support services to help patients identify possible payment assistance programs and other resources to improve access to needed specialty medications.

Depending on the condition, the cost of the therapy, and the patient’s insurance coverage, support from relevant foundations and other sources, such as copay discount cards, may also be sought to help make the proposed therapy affordable.

 Risk Evaluation and Mitigation Strategies (REMS) are required by the FDA to manage known or potential serious risks associated with a drug product and ensure the benefits of a drug outweigh its risks. REMS may consist of several components, including medication guides, communication plans to inform users of risks

Elements to Assure Safe Use (ETASU) requirements

implementation plans, and reporting. All of these components require complex, time-consuming interactions among manufacturers, pharmacies, prescribers, and patients to:		

				Identify the REMS requirements for a specific medication

				Locate materials and identify stakeholders’ individual responsibilities

				Understand how to comply with the requirements

				Report to the pharmacy, manufacturer, and/or FDA.

). PA is required for nearly all specialty medications. Today’s process is primarily retrospective, meaning the need for the PA is not known until after the prescription is written and the pharmacy submits the claim, and efforts to obtain PA begin once the claim is rejected because PA is required. There are multiple routes to obtain PA, which depend on the health plan, drug, pharmacy and patient characteristics, and it may take as long as a week or more to obtain an approval. In addition, the paper forms and portals — the heart of today’s PA non-electronic processes &mdash; require manual reentry of data that may already reside within the electronic health record (EHR). This rework has implications for efficiency and patient safety.

 Specialty medications are not only high cost and touch, but they frequently require special handling procedures such as storage at a controlled temperature. Many are infused or injected at hospitals, physician offices, and clinics, or even patients’ homes.

. Because of the nature of specialty medications and the vulnerable populations who use them, pharmacies and prescribers must coordinate care and monitor patients throughout the treatment timeframe to ensure the efficacy of treatment.

Automating pieces of the specialty pharmacy ecosystem is easier said than done, despite the robust infrastructure that is in place for electronic prescribing (ePrescribing) non-specialty medications and pharmacy claims. Nearly 70% of non-specialty prescriptions are prescribed electronically and more than 700 electronic health records (EHRs) are enabled for ePrescribing. In addition, nearly all retail pharmacies are able to accept and process ePrescriptions.

Recognizing the need for changes in the specialty pharmacy process, NCPDP has been laying the groundwork by identifying gaps and modifying its standards. A new version of the SCRIPT Standard

has been published and is expected to be named this fall as part of the standards updating and adoption process created under the Medicare Modernization Act.

 Members have been proactive in identifying and addressing standards and transactional needs for specialty ePrescribing. For example, members recently voted to add a range of fields to the SCRIPT standard to accommodate information that will greatly enhance the utility and usability of specialty ePrescribing. These include agency and service information, which will allow a provider to indicate the preferred agency and type of service, hospice indicator, IV administration information, and additional patient demographic information. 

Leveraging available data elements related to specialty pharmacy

. NCPDP is also working to drive the use of existing data elements in SCRIPT that are critical to the safe, appropriate, and timely prescribing of specialty medications. These data elements include diagnosis, lab values, height, weight, allergies, and other indicators needed to verify the appropriateness of a prescribed drug and ensure correct dosing. Patient contact information facilitates delivery and clinical services enable the enrollment of the patient in assistance programs. Including these on the electronic prescription expedites pharmacies’ related processes, such as benefit verification and obtaining PA.

. PA is an operational burden for the specialty pharmacy, prescribers and patients. NCPDP has published standard transactions for electronic prior authorization (ePA). Included in the NCPDP SCRIPT Standard, the ePA framework allows prescribers to handle PAs both before (prospectively) and after (retrospectively) a prescription has been written, creating significant reductions in overhead and treatment delays. Questions may be customized by the payer, depending on the patient and the medication involved. Clinical attachments, such as subsets of the medical record, and cancellation and appeal functions are supported. Enhancements continue to be brought forth by the industry and go through NCPDP's standards development process.

 NCPDP also has been active in developing standards in support of streamlining and standardizing the exchange of REMS information. Standardized automation of REMS protocols will increase the speed and accuracy of data provided (including safety information), lower costs to submit and collect data from the various stakeholders, and create an improved audit trail through the process. NCPDP has created new message types, modeled on the ePA transaction structure, and enhanced existing messages to support information exchange. A regulation to name a new version of SCRIPT is expected to be published by November 2016. The new version of SCRIPT will support messages from prescriber to the REMS Administrator prior to sending the prescription. NCPDP has also modified the Telecommunications Standard to allow REMS processing to leverage the claim adjudication process. This new version of the Telecommunications Standard will support pharmacies’ exchange of REMS data. It is not known at the time of this publication when that version will be available.

. Benefit verification is a necessary step in the specialty prescribing process to assist the patient in getting access to the specialty medication. An NCPDP task group is investigating options to support a real-time pharmacy benefit inquiry (RTPBI) that is initiated by the prescriber, instead of relying solely on the formulary and benefit files that are downloaded before the patient visit in today’s current ePrescribing workflow. The RTPBI’s value lies in its potential for providing real-time, patient-specific formulary and benefits information at the point of care. This includes patient-specific utilization management programs (such as PA and step therapy), true out-of-pocket costs for a medication (specific copay/coinsurance amount), and specific deductible information. So far, 11 use cases for the standard have been identified. Industry pilots are underway and the efforts will ultimately be merged to create a new transaction standard.

. Standardized reporting is needed to support contractual arrangements between manufacturers and specialty pharmacies in the areas of order fulfillment, patient census, performance metrics/case management and inventory. NCPDP is currently working to identify all needed data elements and will then develop a report format that will be presented to the membership for approval as a new standard.    

Although much has been accomplished, there still is more work to make the specialty pharmacy ecosystem more efficient and patient-centered. With the goal of establishing priorities in the near term, the SAG decided to focus on the elements that improve speed-to-therapy, as described below. It should be noted that determining the availability of financial assistance is another barrier to providing therapy to patients, but was tabled as it would involve standards and transactions that cross both the medical and pharmacy benefits.

The SAG discussed the problems created by the lack of a specialty pharmacy definition; however, this also was tabled. It was decided that the following would be pursued:

The prescription intake process needs standardization, which can be addressed in both the short and long term. The ultimate goal is electronic submission of the enrollment form, including the prescription, to facilitate triage, processing and dispensing.

. Work will focus on standardizing a pre-adjudication transaction, called Real-Time Pharmacy Benefit Inquiry (RTPBI), which provides information required to dispense a specialty medication.

. Emphasis will be on integrating and streamlining the processes for verifying the patient's, pharmacy's, or prescriber's REMS eligibility. 

 EHR integration of REMS and limited distribution drug (LDD) data available through some compendia can greatly improve speed to therapy if the prescriber is presented with the data prior to prescribing and, further, if the prescriber can then complete the required documentation within their work flow.

. The goal is to adapt the ePA transaction for the unique specialty prescribing work flow. The timely processing of a PA request is key to reducing billing issues and expediting delivery of a specialty medication.

Participants in the SAG have volunteered to reconvene. In the meantime, work on the elements described above will continue through NCPDP’s work groups and task groups. Additional stakeholder involvement is invited and critical.

Various drivers are converging to bring the specialty ecosystem into the digital age. The industry is working diligently to make that a reality, but wider stakeholder involvement will be the key to success. Addressing near-term issues related to the speed of therapy will go a long way to continue moving the adoption needle forward.

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.  Accessed at: http://surescripts.com/news-center/national-progress-report-2014

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Gary Rice is Senior Vice President of Clinical, Education, and Human Resources, Diplomat Pharmacy; Lynnae Mahaney is Executive Director, Center for Pharmacy Practice Accreditation; Anthony Schueth is CEO and Managing Partner, Point-of-Care Partners, LLC; Laura Topor is President, Granada Health, Inc. Author inquiries should be directed to Mr. Schueth, Point-of-Care Partners, 11236 West 49th Street, Coral Springs, FL 33076-2771; tel: 954-346-1999.

Articles

Specialty pharmacy stakeholders need to focus on measureable near-term processes that could improve speed to therapy. 