Solution for Consideration: Medical Tourism and Personal Rx Importation

Transcription

1 Solution for Consideration: Medical Tourism and Personal Rx Importation

2 Agenda 1. Background information on the challenges posed by specialty prescriptions. 2. Medical Tourism; Clinical Pharma Travel Program 3. Personal Importation of Prescription

3 Medical and Prescription $7,000 $6,000 $5,000 $4,000 $3,000 $2,000 $1,000 Plan Costs $1, $1, $1, $1, $1, $1, $4, $4, $4, $4, $4, $4, % after 5 years (3.4% annually) % after 5 years (0.19% annually) $0 Jan10-Dec10 Jan12-Dec12 Jan14-Dec14 Jan10-Dec10 Jan11-Dec11 Jan12-Dec12 Jan13-Dec13 Jan14-Dec14 Jan15-Dec15 Rx Claims Cost PEPY $1, $1, $1, $1, $1, $1, Medical Claims Cost PEPY $4, $4, $4, $4, $4, $4, *includes run-out medical claims The average cost per Rx per employee has increased 38% in the past 3 years which is being driven by high cost specialty prescriptions

4 Prescription Spend by Type (Specialty vs Non-Specialty) $16,000,000 $14,000,000 $12,000,000 $10,000,000 $10,668,680 $2,588,940 $11,879,524 $3,490,901 $13,589,198 $5,346,093 $8,000,000 $6,000,000 $4,000,000 $8,079,740 $8,388,623 $8,243,105 $2,000,000 $ Non-Specialty Rx Specialty Rx *SPECIALTY Rx defined by prescriptions with an average cost over $3,000 Specialty prescriptions with an average cost over $3,000 each is the primary cost driver to the plan. These primarily include the treatment for conditions like Cancer (Oncology), Hep C, MS, Rheumatoid Arthritis, HIV

5 Drugs that cost $3k+ per script in 2015 Unique Members Unique Members Taking Specialty Drugs Total Unique Members Receiving ANY Scripts % of Total Members Receiving Rx 1.5% 1.6% 1.9% Spend Total Spend for Specialty Drugs $2,588,940 $3,490,901 $5,346,093 Total Spend for Non-Specialty Drugs $8,079,740 $8,388,623 $8,126,557 Total Rx Spend for Time period $10,668,680 $11,879,524 $13,472,650 % of Total Spend 22.4% 29.4% 39.7% Script Count # of Scripts for Specialty Drugs Total # of Scripts for Time Period % of Total 0.4% 0.5% 0.6% Avg. Cost Per Script Avg. Cost For Specialty Drugs $4, $5, $6, Avg. Cost For All Drugs $88.31 $94.22 $ Avg. Cost For All Non-Specialty Drugs $68.79 $66.85 $62.24

6 Prescription Spend Per Member Per Year $1,600 $1,400 $1,241 $1,405 $1,200 $1,000 $1,108 $269 $365 $553 $800 $600 $400 $839 $876 $852 $200 $ Non-Specialty Rx Specialty Rx Total Rx Spend Specialty prescriptions with an average cost over $3,000 each is the primary cost driver to the plan. These primarily include the treatment for conditions like Cancer (Oncology), Hep C, MS, Rheumatoid Arthritis, HIV

7 Health City Overview Health City Cayman Islands is a joint venture between Narayana Health and Ascension. Ascension is the largest faith based non-profit, healthcare system in the US. Ascension provides the highest quality care to all with special attention to those who are poor and vulnerable.

8 Examples of Contracts Royal Caribbean Cruise lines Aetna International (Finalizing Agreement) AXA Assistance USA, Inc. Best Doctors Cigna Global Health Companion Global Healthcare Med Retreat National HealthCare Solutions Ltd (NHSI) Quality Health Management LLC United Health International Inc. Rubicon Group Edison Health

9 March 2015 Clinical Pharma-Travel Program Welcome to World-Class, Destination Healthcare

10 Organization Introductory Video

11 Clinical Pharma-Travel Program Pharm-Travel is a program designed for individuals to obtain a clinical review and prescribed medical regimens for significantly reduced cost. Patients who want to or need to reduce the cost of their prescription medications patients who require expensive medications for chronic illness and long term treatment. patients who require as needed medications or a one time dose. Initial focus will be MS, Cancer, RA, HIV, Hep C

12 Clinical Pharma-Travel Program 1. Health City has an initial assessment process that qualifies each candidate for the program, and ensures that the medications are available. When potential patients are recognized as a candidate and medications are secured, patients are sent formal invitations for participation. 2. Once accepted into the program the patient travels to HCCI with their U.S. M.D. s issued prescription(s) to meet with an HCCI specialist 3. HCCI specialist reviews the patient s recent lab work and provides consultation, physical exam if required, any additional screening determined necessary to complete the process, collaborates/acknowledges the appropriateness of the medication and provides a 3 month prescription 4. Rx is filled at HCCI and brought back to the U.S. by the patient. 5. The patient travels to HCCI quarterly for subsequent RXs if needed.

13 Clinical Pharma-Travel Program: Hepatitis C Treatment Health City Cayman Islands is a state-of-the-art tertiary care hospital located in the heart of the Caribbean. HCCI believes no one s socio-economic status should determine their access to healthcare. In line with this vision and mission, HCCI is now offering the new medical treatment for Chronic active Hepatitis C, at a fraction of the US cost. Pasco School District has had at least 7 members supported by Hep C treatment at a cost of over $400,000

14 Evaluation Requirements by HCCI Medical Team during First Visit Complete medical history / records including any complications of liver disease in past, presence of significant extrahepatic disease including ascitis and symptoms of chronic HCV that may diminish quality of life. Detailed medications history is required to analyze drug interactions before dispensing Hep C medications. Any previous or present HCV treatment history with outcome / response ( example cure, resistance, virological failure to any prior Hep C drugs used).

15 INVESTIGATIONS (PREFEREBLY LESS THAN 4 WEEKS OLD) HCV genotype testing 1,2,3,4,5,6 (including subtype, e.g., 1a or 1b) (which was reported at time of initiating first treatment for Chronic Hepatitis C), because the regimes are based on genotype and subtypes PLASMA HCV RNA (quantitative viral load) preferably most recent and all the previous values. It is important to have this recent value as the treatment is initiated based on this value Hemoglobin, hematocrit, WBC with differential, and platelet counts (recent OR at least 4 weeks old) Biochemical markers of liver injury and assessment of hepatic function, including serum ALT,AST,GGT, serum albumin, serum bilirubin (total, direct and indirect direct), INR,Prothrombin time, Fasting Blood glucose (recent OR at least 4 weeks old) If above tests are not done at place of origin, will be done at HCCI at first visit

16 INVESTIGATIONS INVESTIGATIONS (PREFEREBLY LESS THAN 4 WEEKS OLD) Serum creatinine and serum electrolytes (recent OR at least 4 weeks old). Screening Hep B with Serum HBsAg. If positive for Hepatitis B, then - antihbc, antihbs HIV status (HIV 1 & 2 serology), If HIV seropositive current antiretroviral regimens used and degree of viral suppression (baseline report) Serum Creatine Kinase levels (recent) only if patients are on Statins / cholesterol medicines. Clinical assessment for cirrhosis (grade of portal fibrosis). If cirrhotic/suspected progression of portal fibrosis, exclusion of hepatocellular carcinoma based on appropriate imaging study = Ultrasound abdomen pelvis / Elastogram / liver biopsy / CT scan, whichever is appropriate and all past records. The duration of some treatment regimes is for 16 weeks or 24 weeks if cirrhosis has already set in. Urine Pregnancy test (in all women of childbearing age) (4 weeks old). If above tests are not done at place of origin, will be done at HCCI at first visit

17 Treatment & Evaluation Requirements by HCCI Medical Team during Subsequent Visits HCV RNA viral load quantitative testing (during 4 th visit) after finishing the 12 week regime or the 16 week regime, to demonstrate SUSTAINED VIROLOGICAL RESPONSE (SVR) and tell if its cured. If SVR is not seen at 12 th week, then the same test to be repeated after 24 weeks to demonstrate SVR or Virological relapse. The basic chemistry panel at week 4, week 8, week 12 during the regimen period will be serum ALT, AST, GGT, serum albumin, serum bilirubin (total, direct and indirect), INR,Prothrombin time, random blood sugar, and serum creatinine. More frequent monitoring is required if any of these results are not normal during the visits as per concerning results / trends on follow up. Other basic laboratory tests - Complete blood count with differentials at week 4, 8, 12, with more frequent monitoring as per concerning results / trends on follow up.

18 Treatment & Evaluation Requirements by HCCI Medical Team during Subsequent Visits Patients who achieve a sustained virologic response (SVR) after 12 weeks / 3 months of completing the regime and who do not have bridging fibrosis or cirrhosis do not require any specific follow-up for their HCV. Optionally HCV RNA viral load can be repeated after 6 months after the completion of treatment to confirm that the patient has maintained SVR or if SVR was not attained at the end of 12 weeks. Patients who fail to achieve SVR should be followed up for signs of progression of liver disease with Hepatologist. Patients with bridging fibrosis and cirrhosis (advanced or early liver disease) ( > grade 1 fibrosis) regardless of whether they attain SVR, warrant ongoing monitoring and surveillance due to risk of hepatocellular carcinoma or other complications of advanced liver disease.

19 Clinical Pharma-Travel Program: Hepatitis C Treatment On average, there is 94-96% success rate for patients with cirrhosis and 99% success rate with no cirrhosis with current newer directly acting anti- viral regimes (Harvoni regimes). However, there are many personal factors that influence treatment outcomes for individuals. To get a better understanding of how well you re likely to respond to current treatments would be based on the state of liver disease / co- morbidities / genotypes / treatment naïve / past history of virological failure / drug resistance, so be sure to follow your treatment. The success of your treatment can be improved by taking prescribed medicines regularly. How will response to treatment be monitored? Response to treatment is monitored by taking blood tests at intervals to measure the amount of virus in your blood. What the doctor will be looking for is a Sustained Virological Response (SVR). This means that the virus drops to undetectable levels at 12 th week when you finish the prescribed regime and remains undetectable for six months after you complete the treatment. Simply stated, it means you re cured.

20 Clinical Pharma-Travel Program: Hepatitis C Treatment Week 1: 2 Night Stay 28 Days Later: 1 Night Stay 28 Days Later: 1 Night Stay Within 1 Month after completin g 12 weeks regime: Final Review: 1-2 Night Stay HEP-C Package : $25,000 Package Inclusions: Hotel Stay (5-6 Nights Total- $400 USD per night) Air Fare Round Trip (Estimated Max of 1000 per round trip) Drugs, Consultation, and related lab investigations Does not include cost of treatment for any unrelated diagnosis or complications In the event lab investigations are not conducted at HCCI price of the package will be reduced by $1000

21 Concierge Service The team is a centralized, knowledge-based group of professionals addressing the needs, concerns & rights of the patient. With care as the teams central concept, they are the patient liaison: acting between patient, loved ones, health care providers, third party payers and administration to meet every patients needs and create a seamless, effortless flow of events.

22 Clinical Pharma-Travel Program: Hepatitis C Treatment Example of 90 days of treatment for Hepatitis C Traditional PBM Non-Traditional PBM Contract (PCSD Current PBM) Designated Medical Destinations $92,000 $62,000 $25,000* *includes initial assessment and consultation with physician, medication, lab work, hotel, air travel

23 Personal Prescription Importation The drug Lipitor was, for years, manufactured by its patent holder, Pfizer, in an FDA-registered facility in Ireland. The same Lipitor was exported for sale to the U.S. and Canadian markets, ending up in retail pharmacies in both countries. The Lipitor exported to the U.S. was packaged to meet FDA labelling guidelines, while the Lipitor exported to Canada was packaged to conform to the requirements of Health Canada s Therapeutic Products Division, Canada s FDA counterpart. Those Lipitor pills sold in Canadian pharmacies would be considered misbranded if brought into the U.S. and considered illegal if imported by Americans.

24 Personal Prescription Importation The use of FDA resources to provide comprehensive coverage of unapproved new drugs imported for personal use is generally not justified, however, the agency developed guidance in its Regulation Procedures Manual (RPM) entitled "Coverage of Personal Importations" (copy enclosed). This guidance sets forth the agency's enforcement priorities related to the personal importation of unapproved new drugs, with enforcement being focused on products apparently intended for the commercial market and on fraudulent products and those that pose an unreasonable health risk.

25 Personal Prescription Importation FDA Allowances: If you still choose to import prescription medications from outside the United States, be aware that FDA inspectors are allowed to use enforcement discretion to permit the importation of certain unapproved prescription medications for personal use, but that discretion includes these stipulations: The product is for personal use (90 day supply or less). The intended use is for a serious condition for which effective treatment may not be available domestically. There is no known commercialization or promotion to U.S. residents by those involved in the distribution of the product. The product does not represent an unreasonable risk. The individual seeking to import affirms in writing that it is for the patient s own use and give the name of the U.S. physician caring for them or that the therapy is a continuation of therapy begun by a foreign physician.

26 Program Excluded Prescriptions Narcotics and any other Controlled Substance as defined by the FDA Antibiotics or other Non Maintenance Medications including Stat Orders Stat Order: Immediate fill and initiation mandatory in Attending Physician s opinion) Biologics include but are not limited to a wide range of medicinal products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins created by biological processes (as opposed to chemical). Drugs where frequent blood levels are required for titration with respect to narrow therapeutic ranges allied with close clinical observation. Drugs that require cold chain custody / refrigeration to preserve therapeutic efficacy, or any other drug that is supplied in a vial or includes hardware such as needles or syringes for administration Any Drug that is the subject of current or future FDA Consumer Safety Alerts or a Department of Homeland Security Alert or Process Change Additions and deletions to the Formulary will be made to reflect the current status of such alerts or process changes, with timely notification to the affected Member / Plan Sponsor

27 Cialis (Tadalafil) 20mg, 20 tablets, brand 4 $ 3, $ 1, $ 2, % Crestor (Rosuvastatin) 10mg, 90 tablets, Example Prescription Cost Comparison Product option Number of items PBM price Program Cost Savings Percenta ge savings Advair Diskus (Fluticasone/Salmeterol) 250mcg/50mcg, 3 x 60 dose diskuses, brand 2 $ 1, $ $ 1, % Ampyra (Dalfampridine) 10mg, 168 extended release tablets, brand 1 $ 5, $ 2, $ 2, % Arthrotec (Diclofenac/Misopristol) 75mg/200mcg, 180 tablets, brand 1 $ $ $ % Asacol HD (Mesalazine) 800mg, 336 tablets, brand 1 $ 2, $ $ 1, % Bystolic (Nebivolol) 5mg, 196 tablets, brand 1 $ $ $ % Bystolic (Nebivolol) 5mg, 84 tablets, brand 1 $ $ $ % Celebrex (Celecoxib) 200mg, 90 capsules, brand 2 $ 1, $ $ 1, %

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29 Implementation Marketing mail order program Through health centers blasts, portal information page, flyers, etc Members can enroll by calling or register online Prescription can be faxed Shipping typically takes days Reminder notifications are sent around day 60 of a 90 day supply Invoice will be included and processes along with other health center supplier expenses

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