Tip of the Week: Specialty Drugs Have Taken Over (Rerun)

Specialty drugs used to be the novelty part of the drug spend: expensive, yes, but unusual. Ten years ago, specialty accounted for 15% to 20% of the money spent on drugs, but the CVS Caremark 2020 Drug Trend Report shows that specialty drugs accounted for more than half (52%) of the pharmacy spend last year. 

 Evernorth 2020 Drug Trend Report

The 2020 drug trend report from Evernorth (the new Cigna entity that Express Scripts is now part of) also showed that the spend on specialty drugs edged ahead of the spending on traditional medications (50.8% versus 49.2%).

Tyrone’s Commentary:

1) It’s more important than ever to drive high generic drug utilization. A generic dispensing rate or GDR of 80% is not high, relatively speaking. It costs you as much as 2.5% net savings for each 1% below the national average of 90% GDR.

2) Manufacturer assistance programs are a temporary reprieve. First, a drug manufacturer could pull the plug on financial assistance at any moment. More importantly, as more and more new patients initiate a specialty drug therapy regimen, you will find your Rx costs returning back to pre-PAP and pre-CAP program PMPM costs. In a commercial plan, 20 new specialty drug treatments are started per 1000 members annually. Say it with me…cha-ching! Take full advantage of manufacturer derived assistance programs while you can. Restrict the non-fiduciary PBM’s ability to profit from them. The more the PBM benefits from these programs financially the more you and your members pay. 

3) Eliminate expanded drug lists or EDLs. If you choose to keep an EDL as part of the benefit design, restrict them. Are you paid formulary rebates for a drug listed on the EDL? Worse yet, these EDLs create an environment where the relationship between physician and patient becomes transactional. Circumvention of a really good formulary is likely to result in wasteful and/or duplicative spending. 

4)  Lowest net cost formularies, high adherence rates (> 80%) and radical transparency in PBM contracts are and will remain the backbone of an efficiently run pharmacy benefit management program. Be relentless in removing money leaks from employer-sponsored pharmacy benefit programs. That effort starts with achieving radical transparency in your PBM service contract.

5) Education is key to getting to lowest net cost in employer-sponsored pharmacy benefit plans. Only the most sophisticated purchasers of PBM services will have the knowledge and confidence to bind lowest net costs for prescription drugs into contract language and benefit design. Hence, your competitive advantage includes executing good analysis of the correct information then deciding what all of this suggests for your organization. Those who seize the chance and develop a good plan have a higher probability of getting to lowest net cost. 

Five therapeutic categories are driving 90% of the specialty trend for CVS Caremark. Autoimmune is the largest drive because of supplemental indications, which is driving more utilization. The other four were oncology, cystic fibrosis, atopic dermatitis and HIV. New oncology products continue to be a large driver of spending and that in cystic fibrosis you are starting to see patients take more drugs per patient.

Evernorth’s report says 17 of the top 25 drugs ranked by total pharmacy spend were specialty medications in 2020.

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Tip of the Week: The Specialty Drug Pipeline Will Make You Rethink Your Pharmacy Benefits Management Strategy

Employers should be aware that the new drug pipeline focuses on manufacturer investments in developing high-cost brand, specialty and orphan drugs. With more than 8,000 drugs in development, new drug launches will reach historically high levels over the next several years.

New and potentially lifesaving or life-prolonging therapies are reviewed and approved every year, but generally there are two drug pipelines to monitor: novel drugs coming to the market for the first time for any indication, and new indications for existing medications already approved by the U.S. Food and Drug Administration (FDA).
There are several recommended strategies that are proven effective for managing high-cost specialty drugs today. It begins with first understanding the financial and member disruption (i.e., employee retention/recruitment impact) goals for each employer. Then you can focus on these four key areas to ensure a holistic solution is in place to manage costs and appropriate utilization in line with both the contract and clinical perspectives:


1. Maximize contract value:
Obtain the lowest net costs with radically transparent discounts and manufacturer revenue yield through an aligned formulary coupled with an unbiased analysis and independent review strategy. Easier said than done.

2. Evaluate plan design: Examine tiering, copay vs. coinsurance, HDHP vs non-HDHP; Deductibles/Out of Pocket Maximum changes, separate medical/pharmacy accumulators, network design, mail order, Dispense as Written penalties, etc., as well as the extent of each change under consideration (ex: 10% vs 20% coinsurance).
3. Eliminate wasteful spending: Remove questionable low clinical value medications from the formulary; independently review prior authorizations, suspect high-dollar claims, and drugs with the potential to be used off-label; optimize existing therapy and dosing to remedy any per-dose cost improvement opportunities; and independently verify appropriate indication and dosing for complex conditions.
4. Manufacturer assistance programs: Leverage available manufacturer-provided member incentives on specialty medications through a PBM systems-based approach, as opposed to partial carveout solutions that require manual formulary and system manipulations that generate additional risks and inefficiencies.

Tyrone’s Commentary:
Pharmaceutical manufacturers are light years ahead of plan sponsors including both public and private entities. They are keenly aware that the “free” drugs given away today are a temporary slow down of specialty drug spend, for instance. They will continue to innovate and manufacture curative pharmaceutical products. As a result, more and more people will not qualify for patient assistance and/or exhaust coupon savings programs. Many plans will see their drug spend fall back to pre-manufacturer assistance levels in 2-3 years. Specialty drugs will soon account for more than three-quarters (75%) of total drug spend wiping away early gains from manufacturer cost-saving programs. 

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Tip of the Week: Pharmaceutical Manufacturers are Light Years Ahead of Commercial and Public Sector Employers, Unions, Health Plans and Health Systems

Specialty Pharmacies are most often focused on the dispensation of specialty drugs.  While there is no standardized definition of what constitutes a specialty drug, most often the meet the following criteria:
  • the drug is a specialized, high cost product (typically more than $500 per dose or $10000 or more per year)
  • the drug is utilized as a complex therapy for a complex disease
  • the drug requires special handling or administering, shipping, or storage (such as an injectable)
  • the drug may have a Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) in place specifying that there is required training, certifications, or other requirements that must be met in order for the drug to be administered.
  • the drug has the potential for significant waste due to high cost
Specialty drugs are used to treat a variety of complex and chronic conditions including but not limited to: anemia, cancer, infertility, multiple sclerosis, HIV and hepatitis.  Some categorize specialty drugs as meeting all of the three H’s: High Cost, High Complexity, High Touch.
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Because of the specialized way in which these drugs need to be administered, specialty pharmacies come into play with a specific focus on this group of drugs and the required comprehensive and coordinated delivery and support required to effectively deliver these drugs to patients. 

Tyrone’s Commentary:
Pharmaceutical manufacturers are light years ahead of plan sponsors including both public and private entities. They are keenly aware that the “free” drugs given away today are a temporary slow down of specialty drug spend, for instance. They will continue to innovate and manufacture curative pharmaceutical products. As a result, more and more people will not qualify for patient assistance and/or exhaust coupon savings programs. Many plans will see their drug spend fall back to pre-manufacturer assistance levels in 2-3 years. Specialty drugs will soon account for more than three-quarters (75%) of total drug spend wiping away early gains from manufacturer cost-saving programs. Like drugmakers, employers should be planning 4-5 years ahead not waiting until the time comes for renewal. Radical transparency in pharmacy network and manufacturer contracting, efficient benefit design including lowest net cost formularies, and medication adherence programs are hallmarks of good pharmacy benefit management stewardship. Those pharmacy benefit management principles should never take a back seat.

AMS, a healthcare IT company that provides clinical insights and financial analysis of the costliest and most complex medical claims, released their 2020 Specialty Drug Trends Report today, highlighting the need for predictive analytics to combat pervasive drug overspend.

AMS research reveals that payers are not being judicious with their specialty drug expenditures because they have little insight into the actual drivers of high-cost claims and members. Those drivers include cost increases, price transparency issues, and perhaps the fastest-growing area of pharmacy spend, utilization expansion. Detailed cost-driver reporting is needed for payers to alleviate high-cost claim overpayments and predict future liabilities.

Highlights of the report: 

  • Fewer than 2% of the U.S. population utilized specialty drugs
  • Specialty drugs account for more than half (51%) of total drug spend
  • 80% of annual medical trend increases were driven by specialty drug costs
  • The top 10 Medicare Part B covered drugs accounted for 2% of all covered products but 43% of total Part B drug spending


<<Click to Download the Full Report>>

Tuesday Tip of the Week: Specialty Drugs Have Taken Over

 Evernorth 2020 Drug Trend Report

Specialty drugs used to be the novelty part of the drug spend: expensive, yes, but unusual. Ten years ago, specialty accounted for 15% to 20% of the money spent on drugs, but the CVS Caremark 2020 Drug Trend Report shows that specialty drugs accounted for more than half (52%) of the pharmacy spend last year. 

The 2020 drug trend report from Evernorth (the new Cigna entity that Express Scripts is now part of) also showed that the spend on specialty drugs edged ahead of the spending on traditional medications (50.8% versus 49.2%).

Tyrone’s Commentary:

1) It’s more important than ever to drive high generic drug utilization. A generic dispensing rate or GDR of 80% is not high, relatively speaking. It costs you as much as 2.5% net savings for each 1% below the national average of 90% GDR.

2) Manufacturer assistance programs are a temporary reprieve. First, a drug manufacturer could pull the plug on financial assistance at any moment. More importantly, as more and more new patients initiate a specialty drug therapy regimen, you will find your Rx costs returning back to pre-PAP and pre-CAP program PMPM costs. In a commercial plan, 20 new specialty drug treatments are started per 1000 members annually. Say it with me…cha-ching! Take full advantage of manufacturer derived assistance programs while you can. Restrict the non-fiduciary PBM’s ability to profit from them. The more the PBM benefits from these programs financially the more you and your members pay. 

3) Eliminate expanded drug lists or EDLs. If you choose to keep an EDL as part of the benefit design, restrict them. Are you paid formulary rebates for a drug listed on the EDL? Worse yet, these EDLs create an environment where the relationship between physician and patient becomes transactional. Circumvention of a really good formulary is likely to result in wasteful and/or duplicative spending. 

4)  Lowest net cost formularies, high adherence rates (> 80%) and radical transparency in PBM contracts are and will remain the backbone of an efficiently run pharmacy benefit management program. Be relentless in removing money leaks from employer-sponsored pharmacy benefit programs. That effort starts with achieving radical transparency in your PBM service contract.

5) Education is key to getting to lowest net cost in employer-sponsored pharmacy benefit plans. Only the most sophisticated purchasers of PBM services will have the knowledge and confidence to bind lowest net costs for prescription drugs into contract language and benefit design. Hence, your competitive advantage includes executing good analysis of the correct information then deciding what all of this suggests for your organization. Those who seize the chance and develop a good plan have a higher probability of getting to lowest net cost. 

Five therapeutic categories are driving 90% of the specialty trend for CVS Caremark. Autoimmune is the largest drive because of supplemental indications, which is driving more utilization. The other four were oncology, cystic fibrosis, atopic dermatitis and HIV. New oncology products continue to be a large driver of spending and that in cystic fibrosis you are starting to see patients take more drugs per patient.

Evernorth’s report says 17 of the top 25 drugs ranked by total pharmacy spend were specialty medications in 2020.

<<Continue Reading>>

Tuesday Tip of the Week: Optimize Specialty Contracting to Control Costs and Improve Patient Outcomes

Specialty drugs are the future of health care. They are becoming more curative thus require high-contact care coordination and deliberate follow up to guarantee patients stay disciplined and can manage potential side effects to optimize therapy. As a result, payers have looked to narrow their networks as a means to control outcomes, contain costs, and protect revenue which in turn dictates where patients can fill their prescriptions. Today, there is a range of pharmacy options for payers to assess. For the purpose of this blog post, a payer is both a PBM and plan sponsor (third-party), for example.

Health System Specialty Pharmacy (HSSP)

A study by the CDC showed that patients working with an HSSP had an 89% medication adherence rate compared with 74% for patients filling prescriptions at specialty pharmacies outside of their health system. Additionally, well-established HSSPs may have broader access to LDDs or limited distribution drugs compared to larger SPs. HSSPs are on track to become the fastest-growing sites of care over the next 5 years, offering a valuable opportunity for payers to broaden their reach and meet patients at the community-level. HSSPs are uniquely positioned to access both electronic health record and claims data and may provide outcomes assessment data for payers. Patients benefit from a level of high-quality, coordinated care that promotes better adherence and outcomes. It may, however, also come at a higher cost.

Independent Pharmacy

Independent pharmacies that offer specialty dispensing may provide more extensive clinical services in niche therapeutic areas. Additionally, independents often have higher agility in terms of adopting and customizing clinical programs to meet patient and payer needs. While independent SPs may be a part of certain LDD networks, they typically do not have access to the vast majority of specialty drugs on the market.

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Chain Specialty Pharmacy

Chain or major retail pharmacies with specialty channels, have greater access to LDDs than independent SPs. Due to their large number of physical stores, they are a convenient option for patients. However, given the high volume of specialty prescriptions they dispense every day, chain SPs may have less time and bandwidth to dedicate to individualized patient care and follow-up. As a result, they may experience lower customer service ratings compared with other types of SPs. Finally, when the PBM, insurance carrier and specialty pharmacy are all owned by the same organization this convenience often comes with strings attached. Some plans are required to use only the chain’s SP and often forgo rebates in doing so.

Specialty Pharmacy Network

One emerging option for third-party payers is to work with a specialty pharmacy services administration organization (PSAO), a centralized contracting organization that aggregates and supports multiple types of specialty pharmacies at once. Composed of a mix of HSSPs, independent SPs, and medically integrated dispensers, specialty PSAOs create access to a larger network of high-performing pharmacies and enable payers to utilize the trust and familiarity patients have at local and regional facilities, in addition to independents. 

The pharmacy landscape has changed significantly in recent years, and payer networks must follow suit to ensure they are taking advantage of the patient benefits and quality of care each type of pharmacy provides. It’s important for payers to consider how they can evolve and optimize their specialty contracting strategies—not only to control costs, but also to increase patient access to high-quality care that leads to better outcomes.

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Tuesday Tip of the Week: Specialty Drug Utilization Management Three Things to Know

DUM or drug utilization management in specialty pharmacy helps to maximize efficiency. That employers don’t engage in wasteful spending and the right drug, at the right time gets in the hands of the right person. It likewise encourages digital monitoring of the member’s drug therapy in the past, the now and in the future. Here are three imperatives around specialty drug therapy to consider while designing a pharmacy benefit plan:

Imperative 1: Mandate Comprehensive Solutions to Improve Health Outcomes

Specialty pharmacies use medication therapy management (MTM) to coordinate comprehensive care for patients and improve health outcomes. MTM employs a range of clinical tools to improve outcomes and promote value, including therapeutically focused clinical assessments, validated quality of life measures, detailed medication reconciliation, monitoring adverse effects, connecting patients to educational resources, peer-based support programs, and access to need-based financial resources reducing barriers to care. Specialty pharmacies provide patient level support reducing health system and therapy complexity by explaining benefits and coverage, coordinating the best site of care for injected or infused medication, providing drug administration training, adherence support, and resources empowering patients to independently manage complex, persistent treatment plans.

Imperative 2: Evaluate Parity in Pricing for Specialty Drugs

When a specialty medication is parity priced, the drug is the same price regardless of the dose prescribed. For instance, Pomalyst is manufactured in 1 mg, 2 mg, 3 mg, and 4 mg strengths. It is the same price for 1 mg as it is for a 4 mg dose. It is prescribed once per day. QD (qd or q.d.) is once a day; q.d. stands for “quaque die” (which means, in Latin, once a day). BID (or bid or b.i.d) is two times a day ; b.i.d. stands for “bis in die” (in Latin, twice a day). There is no therapeutic benefit for someone to take four 1 mg tablets as opposed to one 4 mg tablet, and yet this is something we see when repricing pharmacy claims files today. Imbruvica and Afinitor are other examples where these cases do not involve changing the drug nor changing the dose. Changing parity priced dosing can save $400K-$500K on a single prescription for a single patient.

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Imperative 3: Take a proactive approach to prior authorizations.

I’ve been fortunate enough to be a “fly on the wall” listening to the leadership teams of several national specialty pharmacies. And while they preach case management and patient care as the priority if you listen carefully what they really want first and foremost is volume or more prescriptions. I am asking self-funded employers a simple yet very important question. Does it make sense to have the same entity manage and approve specialty Rx claims when that entity stands to benefit when these claims are approved? If 85% or more of PAs are getting approved you might be a victim of rubber-stamping which leads to what? You guessed it – wateful spending. Just because you have a PA or step therapy program doesn’t mean it is efficient. Consider carving out the prior authorization process or use prior authorizations with a dollar limit. The goal is not to create disruption but to review the clinical appropriateness of any dose increases, for example.

In conclusion, PBMs will generally manage costs to a level demanded by clients when negotiating their contracts. The best proponent of radical transparency or lowest net Rx cost is informed and sophisticated purchasers of PBM services. In other words, the more you know the less you pay without any reduction in member experience or outcomes.

Tuesday Tip of the Week: Dose Optimization Interventions Yield Significant Specialty Drug Cost Savings

Dose optimization strategies offer a potentially valid, clinically based intervention in which payers can realize a direct drug cost savings, and indirect medical cost avoidance. Dose optimization programs have been evaluated with once-daily, oral maintenance medications using various methods that produced varied results.
These studies were conducted in medication classes such as gastroesophageal reflux disease (GERD), anxiety and depression, and hypercholesterolemia. While the current literature describes dose optimization in the nonspecialty space, there is limited literature on dose optimization strategies used for specialty products.
Oral Oncology Therapies: Specialty Pharmacy's Newest Challenge
Source: Pharmacy Times
A specialty pharmacy developing a dose optimization program could evaluate the implications and viability for specialty products, since they work closely with payers and providers. A successful dose optimization program within a specialty pharmacy could contribute a significant cost savings for payers, further mitigating the rising costs of specialty medications. Therefore, the goal of this pilot program was to evaluate the scenarios and opportunities for dose optimization within a selected group of oncolytics.
Diplomat Pharmacy’s oncology program delivers comprehensive care management to help patients address complex aspects of their treatment and condition. The crossfunctional oncology team is composed of specialized clinicians, and nonclinicians leveraging evidence-based care for treatment optimization, improved care coordination, and therapeutic cost management.

Potential Specialty Generic Drugs 2020

The worldwide Specialty Generic Drugs Market is foreseen to reach USD 190.9 billion by 2025. Specialty Generics drugs are the generic forms of pharmacological drugs. These medications are monetarily less expensive as opposed to brand medications. All things being equal, the turn of events and commercialization of specialty generics drugs are much more complex when contrasted to non-specialty generics drugs.
Organizations are going into the specialty nonexclusive medications market to manufactuer generic forms of drugs by framing new medication formulations. Moreover, the worldwide capacity non-specialty generics drugs is driving organizations to look for more current chances.