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Pandemic Planning Toolkit A resource to assist your organization in preparing for pandemic influenza

TAMIFLU® (oseltamivir phosphate) has been studied only in strains of influenza that were circulating at the time. The magnitude of effect of TAMIFLU in treating and preventing novel strains of influenza, such as those that may be involved in a pandemic, cannot be predicted.

How can my state/territory obtain antivirals for pandemic preparedness?

In anticipation of an influenza pandemic, the United States Government (USG) has identified a need for antiviral drug acquisition by 59 eligible entities (50 U.S. states, the District of Columbia, five U.S. Territories and three Freely Associated States of the Pacific). These entities have the option to purchase antiviral drugs through United States Department of Health and Human Services (HHS)-negotiated contracts.

The ordering period for this contract began on June 29, 2006. Please contact HHS for more details about this program.

INSTRUCTIONS FOR USE OF CONTRACT BY STATES FOR ANTI-VIRAL DRUG PURCHASES

This document summarizes the ordering procedures for the states. It provides the states instructions and requirements for the purchase of antivirals.  Any questions about purchasing under this contract should be directed to the Contracting Officer - HHS - Phone (202) 260-1572 or (202) 205-2978. Fax number is (202) 205-3915. Please refer to Attachment 3 to HHS Contract HHSO100200600015I and Amendment for official ordering contract process.

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1. Who is authorized on behalf of the State to purchase antivirals?

The State Selected Ordering Officer should review the contract and the corresponding Anti-Viral State Allocation Table to become familiar with the terms of the contract as well as the order limitations under the Federal subsidy program.

2. Once the State has determined the number of treatment courses to be ordered, how does the order get placed with HHS?

The State Ordering Officer will determine the number of treatment courses to be purchased (including purchases from local jurisdictions within the state entity).  The State Ordering Officer will prepare a purchase order, with required state approvals, and forward the signed written order to the Contracting Officer at HHS - (202) 205-3979 for review and approval.

Both the State Approving Official and the Ordering Officer must sign all orders placed. The signature must appear on the actual order and shall contain a typed signature block for each individual signature.

In addition, each order shall contain the following fields:

1. Contract Number as referenced in this agreement: HHSO100200600015I;

2. Contact Information: Name of Entity's ordering officer, address, telephone number and fax number;

3. Ship To Location: Name of contact, delivery address, telephone number and fax number;

4. Invoice To: Name of contact, delivery address, telephone number and fax number;

5. Approved Quantity (courses of therapy); Unit Price and Requested Date of Delivery.

* Unit Price: The current contract price for TAMIFLU® (oseltamivir phosphate) is valid until contract expiration on September 1, 2010.

3. How does the State know if HHS has approved the order?

The HHS Contracting Officer will confirm that the order complies with the limits of the program and notify the Contractor (Roche) and will notify the State Ordering Officer that the order can be filled.  This process may take between 2 and 5 days.

HHS will provide Roche with confirmation of the approved quantity for the purchase order.

4. What happens if an order is not approved by HHS?

If any order is not approved, notice will be provided by the HHS Contracting Officer to Roche and guidance will be provided to the State Ordering Officer on the problems with the order.

5. Once an order is approved by HHS, what are the next steps to submit the approved order to Roche?

The State Ordering Officer will forward the original approved purchase order to Roche after confirmation is received from the HHS Contracting Officer. All purchase orders should be forwarded to the attention of:

Christopher Mediano
Product Director, Tamiflu Marketing
1 DNA Way
South San Francisco, CA 94080
Genentech USA, Inc.
1-650-225-1000
Email

6. What happens if a State places an order directly with Roche prior to HHS approval?

If Roche receives an order (order for which the entity is receiving the federal subsidy) directly from any state, Roche cannot fill the order. Roche will direct the state to forward a copy of the order to the HHS Contracting Officer for approval.

7. How does a State include state procurement terms for consideration and/or approval?

Specific terms that will be the responsibility of the States to include in the purchase order are place and time of delivery.

If the state must include state procurement terms and conditions, and/or must have the Contractor (Roche) complete W-9 forms, Contractor Certifications, and proof of Insurance, the State Ordering Officer will contact the Contractor (Roche) to negotiate those state specific terms (ensuring that any of these additional terms or requirements do not conflict with the terms of the HHS agreement) while the order quantities are being reviewed and approved by the HHS Contracting Officer.

If you have general questions regarding this Pandemic Planning Toolkit or require assistance in coordinating an antiviral program for your employees, please contact Roche:

Phone: Pandemic Planning Hotline: (973) 562-2279
Email

8. Can a state place multiple orders under the Federal Subsidy program?

A state may place multiple orders under the Federal subsidy program as long as the total combined quantities purchased do not exceed the limits determined by HHS. All orders must originate from the State Ordering Officer.

9. Can a state place multiple orders that will not be included under the Federal Subsidy program?

A state may place multiple orders that are non-subsidized. All orders must originate from the State Ordering Officer and must be forwarded to the HHS Contracting Officer for approval prior to submission to Roche. The orders must contain the elements as described in (2) above.

10. Can a state request more than one delivery location per order?

Only one delivery location will be allowed for each order.

11. Once an approved order is placed with Roche, what correspondence should be expected from Roche?

Roche will contact the State Ordering Officer with a proposed preliminary delivery schedule. Roche will also confirm the contact information, ship-to information, and invoice addresses.

The Roche Order Fulfillment Team will then use this information to open a direct account for the State's order in preparation for the delivery date.

As the delivery date approaches, the State will be contacted again to confirm location and delivery times.

12. How Does the State Determine How Much Storage Space to Prepare Prior to Delivery?

The state must ensure that adequate storage space, according to TAMIFLU package insert guidelines, must be available prior to the final delivery schedule. See calculator

TAMIFLU state pandemic dosing regimens are in bottles of 10 capsules. The bottles are packaged in cases and arranged in pallets for shipping and storage.

  • Each case contains 48 bottles. Each bottle contains 10 capsules.

  • Each pallet contains 5,184 bottles.

  • Packaging dimensions and storage space requirements are the same for 75mg, 45mg and 30mg dosage formulations.

The dimensions and weight of the bottle, case, and pallet are as follows:

Per bottle:
  • Length, width, depth (cube) = 1.750" x 1.750" x 2.750" = 8.42 sq. in. = 0.0048 cubic ft.

  • Weight = 0.042 lb.

Per case:
  • Number of bottle per case = 48

  • Length, width, and depth (cube) = L 12.625" x W 7.875" x D 6.375" = 0.37 cubic ft.
  • Weight = 3 lbs.

Per pallet:
  • Number of cases per pallet = 108

13. How high can pallets be stacked?

Pallets may be stacked no more than two high.

14. What is the appropriate Temperature storage range?

Store the capsules at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

15. What if delivery locations change?

The State should contact Roche as soon as a change in delivery location is known. It is preferred that these changes in location are provided prior to scheduling a final delivery date.

16. What processes should a State expect on Date of Delivery?

Depending on the quantity ordered, several trucks will arrive at the delivery location. The Roche delivery process includes security measures, and states will be expected to abide by secure procedures.

17. What is the Invoice Payment Process?

Invoices will be submitted the day of delivery. The HHS agreement requires payment within 30 days.

Dosage Subsidized price Total Contract Price
75 mg14.4319.24
45 mg9.7412.98
30 mg6.508.66







If the order is non-subsidized, states will receive an invoice reflecting the total contract price (see table above).

18. Does Roche accept electronic payment through Electronic Funds Transfer (EFT)?

Yes. Roche’s preferred method of payment is Electronic Funds Transfer (EFT). All electronic payments should be made to:

Account Name: Hoffmann-La Roche, Inc.
Account Number: 30551217
Bank Name: Citibank, n.a., New York, NY
ABA Routing Number: 021000089

States who require EFT payment must contact Roche at least two weeks prior to delivery to coordinate EFT information.

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Indications and Important Safety Information

 

Indications

TAMIFLU is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients 1 year and older who have been symptomatic for no more than 2 days.

TAMIFLU is also indicated for the prophylaxis of influenza in patients 1 year and older.

TAMIFLU is not a substitute for early and annual vaccination as recommended by the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP).

Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.

Safety Information

There is no evidence for efficacy against any illness caused by agents other than influenza types A and B.

Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.

No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization.

Efficacy of TAMIFLU has not been established in immunocompromised patients.

Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving TAMIFLU. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on TAMIFLU usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of TAMIFLU to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with TAMIFLU.

The most common adverse events reported >1% of patients treated with TAMIFLU and more commonly than in patients treated with placebo are:

  • Treatment of adult and pediatric patients - nausea, vomiting.
  • Prophylaxis of adult and pediatric patients - nausea, vomiting, abdominal pain.

Vaccination is considered the first line of defense against influenza.

Please see TAMIFLU full Prescribing Information for additional safety information.

 

Roche