Create a business plan report for American National Specialty Pharmacy. Informat
ID: 378690 • Letter: C
Question
Create a business plan report for American National Specialty Pharmacy.
Information of ANSP:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2706163/
http://www.unitedhealthgroup.com/~/media/UHG/PDF/2014/UNH-The-Growth-Of-Specialty-Pharmacy.ashx
Follow the business template below:
1.Mission statement and/or vision statement (what you’re trying to create)
2.Executive overview
3.Feasibility analysis (service and product feasibility, industry feasibility, organizational feasibility, and financial feasibility)
4.Business model (your value proposition)
5.Strategy
6.Marketing plan (How do you plan to grow the business)
7.Summary/Conclusion (everything together)
Explanation / Answer
Business plan report for American National Speciality Pharmacy -
1.Mission statement and/or vision statement (what you’re trying to create)
MISSION STATEMENT – American National Speciality Pharmacy is to transform lives by providing creative, individualised and compounded medications and ultimately maximise the healthcare of patients and reduce the overall cost, which could ultimately make speciality pharmacy reachable to all sections of the society.
VISION STATEMENT – Our mission is to become national leader in speciality pharmacy by providing solutions based on the stakeholders’ real time needs.
2.Executive overview
For anyone concerned with prescription drug price trends, understanding specialty drugs is the first step toward mitigating escalating costs. The purpose of this white paper is twofold: first, to provide an overview of what is driving the specialty pharmacy problem, and second, to propose strategies that can help mitigate runaway costs.
WHAT ARE SPECIALTY DRUGS?
There is no consistent definition of specialty drugs, but they generally have one or more of the following characteristics:
• They are costly (more than $1,000 per month).
• They provide treatment for rare and/or complex, chronic conditions.
• They are difficult to administer or require special handling.
• They are derived from living cells (“biologics”).
Since 2010, the Food and Drug Administration (FDA) has approved more specialty drugs than traditional medications.
Definition of the Specialty Pharmacist Role
Pharmacist whose practice model deals exclusively with medications and pharmaceuticals that are high in cost, require special handling, are subject to limited or restricted distribution, require ongoing assessment, treat rare diseases, or require active monitoring of side effects; with an increased emphasis on patient management, medication adherence, collaboration with other members of the health care team, an ability to use metrics to drive optimization of patient care, and an ability to assist the patient to access additional supportive resources.
Handling and distribution - Because of specialized requirements for handling, delivery, storage, and preparation prior to administration, the distribution of specialty drugs often demands skilled management. As a result, the FDA requires manufacturers to adopt certain practices in this area for distribution of those drugs and manufacturers look to specialty distributers to help deliver their products.31 The dynamics of the supply chain also have changed with companies called specialty pharmacies evolving to address the complexity associated with specialty drugs. Specialty pharmacies have the enhanced capabilities and infrastructure these drugs require and can support complex distribution and patient support services. These companies are playing an increasing role in the marketplace; though they may operate independently, they more often are owned by other entities such as pharmacy benefit managers (PBMs), retail pharmacy chains, wholesalers or health plans. Although traditional pharmacies can dispense specialty drugs, manufacturers may provide some drugs exclusively to specialty pharmacies. For drugs provided under the medical benefit, providers and patients also may rely on specialty pharmacies to access those drugs (though may also do so directly with manufacturers).
Benefit structure - When patients administer specialty drugs themselves or take them orally, the pharmacy benefit associated with their health plan generally provides coverage, often through the use of a PBM. In contrast, when a health care provider administers specialty drug therapies, payers tend to cover the drugs and the related therapy as part of a medical benefit, which has a different approach to payment. Physicians administering intravenous specialty pharmaceuticals under the medical benefit purchase the drugs and then seek reimbursement from payers in a process called “buy and bill.” Hospital outpatient facilities also purchase those drugs themselves, negotiating their own arrangements with manufacturers, and bill payers for the drugs as part of the overall service. Slightly more than half of total spending on specialty drugs across all payers is for drugs covered under the pharmacy benefit: $39 billion in medical benefit drugs, and $48 billion in pharmacy benefit drugs in 2012.When spending is broken down by clinical condition, a more complex picture emerges. For some conditions—for example, multiple sclerosis or growth deficiency—most specialty drug spending falls under the pharmacy benefit. That means that patients using those drugs tend to self-administer and PBMs/ specialty pharmacies negotiate the drug price. For most cancers, the opposite is true, with most spending covered under the medical benefit and providers playing a role in drug acquisition.
3.Feasibility analysis (service and product feasibility, industry feasibility, organizational feasibility, and financial feasibility)
Market Assessment
An evaluation of specialty pharmacy services must also include an initial market assessment to help identify potential marketplace competition and other sources that could hinder patient volume and prescription capture rate. Established large national specialty pharmacy distributors may have a significant competitive advantage. There must be careful consideration to determine how the specialty pharmacy is going to be able to outperform these national specialty pharmacies. Many of these distributors were established at the beginning of the specialty pharmacy era and have a large portion of the market share. Additionally, it is likely that patients have been utilizing their services for an extended period of time, which could present a challenge when encouraging patients to start using the health-system specialty pharmacy. When marketing the health-system pharmacy to attract patients, focus on promoting increased access, decreased time to therapy, and enhanced communication. Keeping patients within the health-system network enhances patient care, allows the collection of outcomes data, and closes the loop on transitions of care. Overall, health systems need to perform a market assessment of the specialty pharmacy that is patient-centric, identifies unique features that separate it from the competition, and demonstrates its ability to improve clinical and economic outcomes for patients.
Financial Modeling
After conducting an existing market survey, the next critical step is to develop financial analysis models that fit the proposed specialty pharmacy plan. This financial model must be conservative yet realistic and encompass short- and long-term planning for the prospective specialty pharmacy. The financial plan must be based on payer contracts that are competitive with large, national specialty pharmacies such as CVS Caremark, Accredo, and Diplomat. The level of competiveness with contracting and the prescription capture rate will determine how many patients can be served within the health-system pharmacy; this will be a key factor in determining the payback period during the initial ramp-up timeline. The process of obtaining specialty medication contracts can take several months to finalize, and third-party consultants may be needed to help expedite the process. This additional time needed for start-up should not discourage health systems from starting a specialty pharmacy, however, it should be factored into the total time needed for payback of the capital investment and other start-up costs.
Contracting
Obtaining and maintaining payer contracts and specialty manufacturer limited distribution agreements is the most important aspect of the start-up, implementation, and continued growth of a healthsystem specialty pharmacy. When negotiating payer contracts, it is important to recognize all of the resources available to the institution and to the specialty pharmacy. In many cases, pharmacy departments can work with their health-system payer contracting department to help facilitate the negotiation and contract development process of starting a specialty pharmacy. Additionally, academic medical centers can utilize the University Health- System Consortium (UHC) to help provide leverage when negotiating payer contracts and manufacturer contracting for limited distribution drugs. Smaller, non-UHC member hospitals interested in starting specialty pharmacy services can utilize numerous pharmacy consulting companies that can help obtain specialty contracts based on previous payer and distributor relationships and other strategies. These consulting firms may also be able to devise unique specialty pharmacy models for smaller hospitals that can be as beneficial as a full-service health-system specialty pharmacy.
4.Business model (your value proposition)
Our values –
a. Integrity – We deliver with total sincerity, transparency and honesty towards all our stakeholders, providers and partners.
b. Respect in Culture – Culture of gratitude, trust and respect is inculcated and practised.
c. Dedication – We sincerely care and dedicate ourselves and our actions towards the needs of patients and provide them unrivalled care.
d. Mutual Growth – We believe in mutual growth and create awareness amongst our patients, partners, providers and ourselves.
e. Support – Our staff supports each other and create effective teamwork.
f. Innovation - We approach positively towards challenges and innovate creative strategies which exceed expectations.
5.Strategy
SIX MITIGATION STRATEGIES FOR SPECIALTY DRUG MANAGEMENT
While there is no silver bullet to manage specialty drug spend, plan sponsors that adopt a multifaceted approach can mitigate the expected cost increases. Focusing on the following areas can yield important benefits.
1. Contracts Can Incorporate Favorable Terms Specialty drug contract terms are the first line of defense in pharmacy program management. While that may sound obvious, it is important to note that specialty drug contract terms have historically been even less transparent than other PBM contract terms. Maximizing the value of specialty discounts will ensure that the price is as low as possible. Many PBMs will require exclusive specialty dispensing at a preferred pharmacy or pharmacies to maximize discounts, with typically a 1–2 percent improvement on discounts. PBMs also typically have a specialty drug fee schedule that outlines the discount by drug without providing an aggregate specialty guarantee. An aggregate guarantee will protect your bottom line even if the drug mix changes. Additionally, many PBMs have inflation cap agreements with specialty manufacturers. If manufacturers exceed these caps, then plan sponsors will be compensated for the overage via rebates. Specialty rebates have increased at exponential rates in recent years as a result of these inflation protection programs.
2. Stringent Requirements Can Be Imposed by Formularies - All PBMs offer core formulary strategies; however, many have taken additional measures to drive competition among specialty manufacturers. The fourth-tier specialty copays that were prevalent five years ago are no longer the norm, as PBMs have begun to place specialty products in preferred and non preferred formulary tiers. Some have even adopted strategies that exclude non preferred products. These strategies drive competition to reduce prices, increase rebates, and steer patients to more cost-effective and clinically appropriate drugs. In addition to these formulary strategies, most specialty drugs, especially those in tier 3, also require prior authorization to ensure that the patient meets all the necessary clinical criteria to receive the specialty medication.
3. Care Management Teams Can Add Value to Specialty Rx Exclusive Networks A common value-add of an exclusive specialty network is a high-touch care management team specifically for specialty patients. However, patients are not necessarily required to engage with the case managers. Incentives or requirements to engage with case managers can help patients manage side effects, comorbidities, administration of the medication, and coordination with the prescriber.
4. Manufacturer Coupons and Incentives Can Reduce Costs As the market has evolved, additional tactics have surfaced to take advantage of industrywide programs offered by manufacturers. Most specialty manufacturers offer financial assistance programs, some of which are not need-based. Manufacturers provide a set assistance amount for particular specialty medications regardless of patients’ health plan coverage. This practice has undermined formularies and plan designs. Furthermore, the patient and plan sponsor frequently fail to maximize the value of the copay assistance.
Here is an illustrative example - Let’s say a $750 per month copay assistance program is available for Enbrel, and Employer ABC’s health plan has a $50 per month copay for the drug. Without coordination by the PBM, the member could fill a prescription at no cost, since his or her copay is less than the $750 available in copay assistance. In that case, Employer ABC’s plan would receive no benefit. If Employer ABC were to adopt the copay assistance program, its PBM would administer an $800 copay, which would equate to the $50 member copay and the $750 copay assistance from the manufacturer. Many PBMs are automatically enrolling patients in copay assistance programs without ensuring that the prescribed drug has preferred status in the formulary or ensuring that the plan sees any savings from the copay assistance programs. This is good for the member financially but can be a challenge for the plan in terms of long-term cost management and (potentially) clinical outcomes. The program should be structured so that the formulary and benefit levels are preserved. If plan sponsors adopt more rigorous copay assistance management, extensive communications will be needed, as the assistance amounts vary by drug.
5. Site-of-Care Alignment Can Reduce Costs Significantly - In addition to specialty medications dispensed at the pharmacy, about 30–40 percent of specialty spend falls under the purview of the medical carrier. A site-of-care alignment strategy removes costly infusions from inpatient and outpatient settings and drives members to home infusions or infusion centers. The result is less price fluctuation (as PBMs are held to different financial standards), lower provider and facility charges, and generally more convenient infusions for patients. Coordination with the medical program is critical to ensure consistent communication to both members and providers on preferred network strategies.
6. 340B Strategy Can Yield Shared Savings - Employers with significant use of 340B hospitals (those that serve a disproportionate share of patients enrolled in federal- or state-sponsored medical programs) may be able to leverage 340B pricing on specialty drugs filled at the PBM’s specialty pharmacy. PBMs and specialty pharmacies frequently contract with 340B providers to take advantage of their preferred acquisition costs for specialty drugs. If a specialty prescription is written by a 340B prescriber and the drug is dispensed at a contracted pharmacy, the pharmacy will see a much higher margin on those medications, as it is “restocking” its shelves at the 340B price. The pharmacy/PBM will generally not pass on the full difference to the patient but will share in some of the additional savings from the program. This strategy may result in 1–2 percent savings on specialty spend with no member disruption, depending upon 340B prescribing practices.
6.Marketing plan (How do you plan to grow the business)
• Engage medical staff leadership from Departments of Medicine, Neurology, & Transplantation
• Engage practice managers, clinic nurses & social workers
• Jointly develop metrics to ensure benefits to both patients & providers
• Use starter packages to reduce waste
• Develop patient SP brochures for each clinic
• Target Medicare and Medicaid patients – goal of 60% market share in year three
• Join UHC SP program for additional access to limited distribution medications and insurer/PBM contracts
7.Summary/Conclusion (everything together)
Implementing specialty pharmacy services can be an effective way for health systems to generate additional revenue, increase patient access to clinical management services, and develop an enhanced model for coordinating patient care. The opportunities and benefits of implementing specialty pharmacy services can be substantial, but alternative options can bring value to your institution by helping you manage excess costs and enhance the continuity of care for patients.