Maybe you’ve noticed: medications are getting more complicated, more personalized, and more expensive.
Look at some of the recent drugs approved for cancer, hepatitis C virus, or rheumatoid arthritis. These are three very different conditions, but many newer drugs used to treat these conditions have common traits: they are targeted or personalized treatments for complex medical conditions, are biologic products with a host of serious side effects that require monitoring, and can be very, very costly.
IQVIA estimates the global pharmaceutical market will exceed $1.5 trillion by 2023. Over two-thirds of launches in the next 5 years will be specialty products, lifting specialty share of spending to near 50% by 2023 in most developed markets. Many of the costs shared for specialty drugs come out of a patient's pocket.
You should have the right to understand and make informed decisions about your medications -- the pros and cons -- as well as important cost issues. All of these are areas a specialty pharmacy can help educate you about; however, many patients are confused about these services and exactly how they work.
Here's a few questions you might have:
Why can’t I just go to my regular pharmacy to fill a specialty drug prescription?
Why do I have to fill out forms, go through education, and spend time learning about the drug?
Why can't some medications be kept in my local pharmacy right down the road?
If I receive specialty medications via mail-order, can I trust medications from a pharmacist and pharmacy that I am likely to never meet or see?
How can I be expected to handle a complicated and often enormously costly prescription?
What Is A Specialty Pharmacy?
As noted by the American Pharmacists Association, a specialty pharmacy provides distribution of specialty, high cost medications. There is also a high-touch and patient-centered management system to positively benefit the patient’s experience. Patients receiving these medications require a significant degree of continuous patient education, ongoing monitoring, and medication management by skilled pharmacists. Ideally, this improved care model will lead to measurable, positive clinical outcomes.
A specialty pharmacy will stock many of the drugs that are not usually found in your community or retail pharmacy.
Some medications are required by the FDA to be prescribed and dispensed only by certified doctors and pharmacists, and specialty pharmacies may provide these drugs, along with required education and monitoring.
This type of pharmacy takes a one-to-one personalized approach to patient care and has a dedicated, trained staff of professionals to help review, dispense, and monitor your medication treatment.
Contact is usually covered via an extended hour, 7 day-a-week staff of health care professionals, including licensed pharmacists and nursing personnel.
A specialty pharmacy is usually a subset of a larger health insurance provider, retail provider, or pharmacy benefit manager (PBM) that coordinates these services, although independent specialty pharmacies also exist. Some of the top Specialty Pharmacies in the U.S. include:
CVS Caremark
Accredo
Walgreens Specialty Pharmacy
Optum Rx
Diplomat Pharmacy
Prime Therapeutics
These pharmacies may not be located in your town, or even in your state, but the healthcare professionals will keep in contact with you via phone or computer and mail your medications so you can get them safely and on time.
Even medications that require refrigeration can be shipped with a cold pack. Supplies, such as syringes, alcohol swabs, and sharps kits, if required, may be supplied as well as overnight express mail service. Online access to your pharmacy profile is available.
A pharmacist or nurse will initiate follow-up care to remind you when it is time to refill your prescription, check on your therapy progress, and answer your questions to help you stick with your therapy. A specialty pharmacy works closely with you - the patient - to provide a personalized plan of care to optimize your medical outcomes and safety.
What Medical Conditions Are Covered By A Specialty Pharmacy?
Common chronic, conditions that a may be covered for specialty pharmacy care include:
Anemia
Cancer
HIV
Infertility
Multiple Sclerosis
Rheumatoid Arthritis
Growth Hormone Deficiencies
Hepatitis C Virus
Hemophilia
Psoriasis
Pulmonary Hypertension
Crohn’s Disease
Individualized education is at the forefront of specialty services to be sure you feel comfortable and understand your medication. Often, you as the patient will be teamed up with a care coordinator that can answer your questions about your medication, provide disease education, and even help you secure payment for your medications when you cannot afford them or don’t have adequate insurance.
Your care coordinator will work closely with your doctor to be sure your medication and dose are appropriate, screen for drug interactions, monitor for side effects, and be sure that refills are shipped in a timely manner.
Unnecessary costs can be avoided and professionals will work on your behalf to make sure you can take your medication without fail.
What Is A Specialty Drug?
Specialty-type drugs have been growing rapidly over the last two decades. These drugs are FDA-approved to treat complex medical conditions and rare diseases, and are often very expensive and require special storage, preparation, and handling. They can be taken orally, injected, inhaled or given by infusion.
As new information is learned about diseases, novels drugs like biologics, targeted therapies, and personalized medicine will expand. Many of these new therapies are prolonging survival for patients or boosting their quality of life.
These drugs also continue to get more and more expensive, often to the point where someone without insurance cannot afford them. However, there may be options to explore to help you if cost is an issue.
Most drugs classified as specialty drugs have these criteria:
Used in a complex medical condition.
High cost; often tens of thousands of dollars per year.
Special administration, handling, shipping or storage is required (for example: an injection, cold storage needed, or direct mail to a physician).
The drug may have limited access or required certification of health care professionals who are prescribing, administering or dispensing the drug. Sometimes these drugs are part of a REMS program mandated by the FDA.
May be used in rare disease states which occur in less than 200,000 people nationwide (these are called "orphan drugs").
Examples of Drugs Often Coordinated by Specialty Pharmacies:
Actemra (tocilizumab) - rheumatoid arthritis
Afinitor (everolimus) - cancer; kidney, breast cancer, or brain tumor
Atripla (efavirenz, emtricitabine, and tenofovir) - HIV
Aubagio (teriflunomaide) - multiple sclerosis
Avastin (bevacizumab) - cancer; various tumor types like brain, kidney, lung, colon, rectum, cervix, ovary, or fallopian tube.
Avonex (interferon beta-1a) - multiple sclerosis
Botox (onabotulinumtoxinA) - a neuromuscular blocker
Cyramza (ramucirumab) - stomach cancer, colorectal cancer, or non-small cell lung cancer
Enbrel (etanercept) - rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, polyarticular juvenile idiopathic arthritis in children.
Entyvio (vedolizumab) - ulcerative colitis and Crohn’s disease
Esbriet (pirfenidone) - a lung disease called idiopathic pulmonary fibrosis (IPF)
Forteo (teriparatide) - osteoporosis
Gilenya (fingolimod) - multiple sclerosis
Gleevec (imatinib) - cancer; leukemia (blood cancer), bone marrow disorders, skin cancer, certain tumors of the stomach and digestive system.
Harvoni (ledipasvir and sofosbuvir) - chronic hepatitis C
Humira (adalimumab) - rheumatoid arthritis, Crohn’s disease, plaque psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis.
Ibrance (palbociclib) - advanced breast cancer
Imbruvica (ibrutinib) - cancer; mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL)
Iressa (gefitinib) - non-small cell lung cancer
Kalydeco (ivacaftor) - cystic fibrosis
Keytruda (pembrolizumab) - for metastatic melanoma (advanced skin cancer)
Kineret (anakinra) - rheumatoid arthritis, neonatal-onset multisystem inflammatory disease
Lupron Depot (leuprolide) - prostate cancer in men, endometriosis in women, precocious (early-onset) puberty in children
Orencia (abatacept) - rheumatoid arthritis
Otezla (apremilast) - psoriatic arthritis, plaque psoriasis
Perjeta (pertuzumab) - HER2-positive breast cancer
Plegridy (peginterferon beta-1a) - multiple sclerosis
Pomalyst (pomalidomide) - cancer; multiple myeloma
Remicade (infliximab) - rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, severe or disabling plaque psoriasis.
Revlimid (lenalidomide) - anemia, cancer; multiple myeloma, mantle cell lymphoma, myelodysplastic syndrome.
Rituxan (rituximab) - cancer; non-Hodgkin's lymphoma or chronic lymphocytic leukemia; rheumatoid arthritis.
Soliris (eculizumab) - paroxysmal nocturnal hemoglobinemia (PNH), atypical hemolytic uremic syndrome (aHUS)
Sovaldi (sofosbuvir) - chronic hepatitis C virus
Opdivo (nivolumab) - cancer; metastatic melanoma (advanced skin cancer)
Stelara (ustekinumab) - psoriatic arthritis, plaque psoriasis
Tysabri (natalizumab) - multiple sclerosis, Crohn’s disease
Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir) - chronic hepatitis C genotype 1
Xalkori (crizotinib) - non-small cell lung cancer
Xeljanz (tofacitinib) - rheumatoid arthritis
Xeomin (incobotulinumtoxinA) - neuromuscular blocker
Xolair (omalizumab) - chronic hives (idiopathic urticaria), severe asthma
Xtandi (enzalutamide) - prostate cancer
Zortress (everolimus) - prevent organ rejection after a kidney or liver transplant
Zytiga (abiraterone) - metastatic prostate cancer
Is There Help in Paying for Specialty Medicines?
The cost of specialized medications is often a shock for patients. For example, the antiviral hepatitis C medication called Sovaldi (sofosbuvir) costs roughly $1,000 per pill, taken once daily over a 12-week or 24-week period. This can quickly add up if you do not have insurance coverage. Plus, it is taken with at least one other medicine.
Specialty pharmacies will usually file your insurance claim for you and take care of the details known as “prior authorization” to help get your medication covered.
They will contact the insurance company and even determine the paperwork that needs to be completed. They will work on your behalf if a claim is denied.
Be sure to notify your care coordinator if your health insurance benefits should change in any way.
It’s not unusual for specialty meds to run into the tens or even hundreds of thousands of dollars.
Your specialty pharmacy care coordinator can refer you to a financial assistant that may know of alternative ways to help you pay for your drugs; for example, through a manufacturer’s Patient Assistance Program (PAP) or a state assistance program. The Patient Advocate Foundation may be another source. Call the manufacturer of your drug to learn more about Patient Assistance Programs.
Be sure to ask your health care providers for other sources of financial assistance on high-cost medications that you are unable to afford. These services can lower your out-of-pocket expenses and allow you to take a medication you would otherwise not be able to afford.
If you cannot afford your medications, or have no assistance, have a frank discussion with your healthcare provider about other alternatives or options. They are always glad to offer help and advocate for you in any way possible.
For More Information
Sources
The global use of medicine in 2019 and outlook to 2023. IQVIA institutes. Accessed May 7, 2021 at https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023
Drug spending growth to come solely from specialty meds, report says. ZBioPharmDive. Accessed May 7, 2021 at https://www.biopharmadive.com/news/drug-spending-increase-2018-specialty-meds/519001/
Specialty Pharmacy. APHA. Accessed May 7, 2021 at https://pharmacist.com/Practice/Patient-Care-Services/Specialty
Hirsch BR., Suresh B., Schulman KA. Spending On Specialty Pharmaceuticals: The Impact Of Specialty Pharmaceuticals As Drivers Of Health Care Costs. Health Aff. 33:101714-20. doi:10.1377/hlthaff.2014.0558
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